Therapeutic Goods Administration
Attachment 1: Expanded list of permitted indications
Ref
No
Proposed permitted indication
1
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Antioxidant
Oral
0AO-00-US-00-S00
SAN08
Antioxidant
2
Traditionally used in herbal medicine as a
mild antiseptic
Topical
0AT-MI-US-00-THM
HC
Traditionally used in Herbal Medicine as a mild
antiseptic
3
Helps strengthen bone and tissue in
growing and mature users.
Oral
0BS-00-SN-00-SCO
CALC2
Source of calcium. A calcium supplement
formulated to strengthen bone and tissue in
growing and mature users. (or) Source of calcium.
A calcium supplement formulated to strengthen
bone and tissue for children and older adults.
Helps in the development and
maintenance of bones and teeth
Oral
0BT-00-DM-HE-S00
HC
Helps in the development and maintenance of
bones and teeth (optional: "especially in childhood,
adolescence and young adulthood").
Helps in the development and
maintenance of bones and teeth especially
in childhood, adolescence and young
adulthood
Oral
0BT-00-DM-HE-SCA
HC
Helps in the development and maintenance of
bones and teeth especially in childhood,
adolescence and young adulthood
6
Helps maintain cell health
Oral
0CE-HE-MA-HE-S00
FNFC
Helps to maintain the cell health
7
Helps in connective tissue formation
Oral
0CT-00-FO-HE-S00
HC
Helps in connective tissue formation
8
Helps to produce and repair connective
Oral
0CT-00-PD-HE-S00
HC
Helps to produce and repair connective tissue
4
5
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 1 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
tissue
9
Helps strengthen connective tissue
Oral
0CT-00-SN-HE-S00
BM17
Strengthen connective tissue
10
Supports energy production
Oral
0EY-00-PR-SU-S00
SAN10
Supports energy production
11
Helps to support a modest reduction in fat
mass when used with a program of
reduced intake of dietary calories and
increased physical activity
Oral
0FM-MR-SU-HE-S00
HC
May help to support a modest reduction in fat mass
when used with a program of reduced intake of
dietary calories and increased physical activity
12
Supports foetal growth and development
Oral
0FO-GD-SU-00-S00
SAN12
Required for foetal growth and development
13
Contributes to the normal growth of the
foetus
Oral
0FO-GR-CO-00-S00
FNFC
Contributes the normal growth of the fetus
14
Assists in the maintenance of normal
healthy blood sugar/glucose balance in
healthy individuals.
Oral
0GB-NH-MA-AS-S00
BLDGL03
May assist in the maintenance of normal healthy
blood sugar/glucose balance in healthy individuals.
Assists in the maintenance of normal
healthy glycaemic controls in healthy
individuals.
Oral
0GC-NH-MA-AS-S00
BLDGL02
May assist in the maintenance of normal healthy
glycaemic controls in healthy individuals.
16
Helps normal growth and development
Oral
0GD-NO-HE-00-S00
HC
Helps normal growth and development
17
Assists in the maintenance of normal
healthy blood sugar/glucose levels in
Oral
0GL-NH-MA-AS-S00
BLDGL01
May assist in the maintenance of normal healthy
blood sugar/glucose levels in healthy individuals.
15
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 2 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Used in herbal medicine as supportive
therapy for the promotion of healthy
glucose levels
Warning HS,
BSL required
Oral
0GL-HE-PR-SU-NHM
HC
(Used in Herbal Medicine as) supportive therapy
for the promotion of healthy glucose levels
Used in Traditional Chinese Medicine
(TCM) to relieve gum, mouth and throat
complaints
Warning S
Oral
0GM-CO-RE-00-TCM
HC
Traditionally used in TCM to relieve gum, mouth
and throat complaints (Bown 1995a, Bensky and
Gamble 1993)
Helps normal growth
Oral
0GR-NO-HE-00-S00
HC
Helps normal growth
Helps improve general health / well being
Oral
0HE-GE-IM-00-S00
WELL1
Aids, assists or helps in the maintenance of general
well-being
Helps maintain general health / well being
Oral
0HE-GE-MA-00-S00
WELL2
Aids, assists or helps in the improvement of general
well-being
Promotes general health.
Oral
0HE-GE-PR-0-S00
PERI3
May assist in maintaining peripheral circulation
and promoting general health.
healthy individuals.
18
19
20
21
22
23
24
25
For the maintenance of good health
Oral
0HE-GO-MA-00-S00
HC
Source of vitamin A/essential amino acid/essential
fatty acids/linoleic acid (LA)/omega-3 fatty
acids/omega-6 fatty acids/eicosapentaenoic acid
(EPA) and docosahexaenoic acid
(DHA)/Provitamin A for the maintenance of good
health
Provides antioxidants for the maintenance
Oral
0HE-GO-MA-AO-S00
HC
Provides antioxidants for the maintenance of good
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 3 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
of good health
26
Helps in the maintenance of good health
27
Used in Traditional Chinese Medicine
(TCM) to support the healing of minor
injuries
28
29
30
31
32
33
Source indication
health
Oral
0HE-GO-MA-HE-S00
HC
A factor in the maintenance of good health
Warning S
required
Topical
0IN-00-HE-PR-TCM
HC
Traditionally used in TCM to promote healing of
injuries (Bown 1995a, Bensky and Gamble 1993)
Helps reduce minor inflammation
Warning S
required
Oral
0IN-00-RD-HE-S00
SAN07
Antiinflammatory
Traditionally used in herbal medicine to
help soothe minor inflammation
Warning S
required
Topical
0IN-MI-SO-HE-THM
HC
Traditionally used in Herbal Medicine to help heal
minor cuts and wounds (vulnerary) and to help
soothe minor inflammation by topical application
Oral
0MC-HE-MA-HE-S00
SAN15/FN
FC
Beneficial for healthy skin/helps to maintain skin
and mucosa healthy
Helps to maintain healthy mucosa
Traditionally used in herbal medicine as a
tonic to strengthen and soothe the mucous
tissue of both respiratory and gastrointestinal tract
Oral
0MC-RG-SS-TO-T00
HC
Traditionally used as a tonic to strengthen and
soothe the mucous tissue of both respiratory and
gastro-intestinal tract (Blumenthal 1998; Hoffman
1996; Felter and Lloyd 1983).
Beneficial to men in satisfying
physiological requirements of the male
body.
Oral
0ME-00-BE-00-S00
MALE2
Male support. May be beneficial to men in
satisfying physiological requirements of the male
body.
Balances and supports normal male
reproductive function.
Oral
0ME-00-BS-00-S00
MALE1
Male support. Balances and supports normal male
physiology and function.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 4 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used in Ayurveda for
memory enhancement
HS
Oral
0ME-00-EN-00-TAY
HC
Traditionally used in Ayurveda for memory
enhancement (Upton 2000, Nadkarni and Nadkarni
1954)
35
Helps to enhance memory in adults
HS
Oral
0ME-00-EN-HE-SAD
HC
Helps to enhance memory in adults
36
Nutritional and herbal support designed
to supply masculine needs.
Oral
0ME-00-SE-00-S00
MALE3
Male support. Nutritional and herbal support
designed to support and enhance masculine needs.
37
Increases [fat-free/body/muscle/lean]
[mass/size] when used in conjunction
with a resistance training regimen and a
healthy energy-controlled diet
Oral
0MM-00-IN-00-S00
HC
Increases [fat-free/body/muscle/lean] [mass/size]
when used in conjunction with a resistance
training regimen
38
Helps to assist in muscle cell repair after
exercise
Oral
0MU-CR-AS-HE-S00
HC
Helps to assist in muscle cell repair after exercise
39
Helps to maintain proper muscle function
Oral
0MU-FU-MA-HE-S00
HC
Helps to maintain proper muscle function
40
Assists in the management of the
symptoms of over-indulgence such as
indigestion, constipation, bloating and
fatigue.
Oral
0OI-00-MG-AS-S00
GAST11
May assist in the management of over-indulgence.
Relieves the symptoms of overindulgence
such as indigestion, constipation, bloating
and fatigue
Oral
0OI-SY-RE-00-S00
GAST6
34
41
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
For the symptomatic relief of overindulgence.
Page 5 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
HC
Used in Herbal Medicine to help enhance physical
capacity/performance (in cases of physical stress)
(ESCOP 2003 , WHO 1999 , Gross et al. 1995 , Kim
et al. 2005 , Schepdael 1993 , Sotaniemi et al. 1995 ,
Gross et al. 2002 )
42
Used in herbal medicine to help enhance
physical capacity/performance in cases of
physical stress
Oral
0PC-00-EN-HE-NHM
43
Topical
0PI-00-RE-HE-TAY
HC
Traditionally used in Ayurveda to relieve pain and
inflammation, and assist in the healing of minor
wounds such as cuts and burns, and minor skin
irritations
Traditionally used in herbal medicine as a
galactogogue/lactogogue to help promote
milk production/secretion
Oral
0PS-MI-PR-HE-THM
HC
Traditionally used in Herbal Medicine as a
galactogogue/lactogogue to help promote milk
production/secretion
Used in Traditional Chinese Medicine
(TCM) to reinforce qi (vital energy)
Oral
0QI-00-RI-00-TCM
HC
Used in TCM to reinforce qi, benefit the spleen and
lung, relieve symptoms of thirst due to impairment
of body fluids and internal heat
Used inTraditional Chinese Medicine
(TCM) to promote circulation of qi (vital
energy)
Oral
0QI-CI-PR-00-TCM
HC
Traditionally used in TCM to promote circulation of
qi (Long 1998, Bensky and Gamble 1993)
HC
Used in Traditional Chinese Medicine (TCM) for
deficiency of qi and yin, internal heat, cough and
asthma, bloody phlegm, fire in the deficiency
syndrome, dysphoria and tiredness, dry and thirsty
mouth and throat (PRC 2005)
Traditionally used in Ayurveda to relieve
pain and minor inflammation
44
45
46
47
Used in Traditional Chinese Medicine
(TCM) for deficiency of qi (vital energy)
and yin, internal heat, cough, cools heat
from yin deficiency, tiredness, dry and
thirsty mouth and throat
Warning S
required
Warning S,
COU1 & COU2
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Oral
0QI-DE-US-00-TCM
Page 6 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
48
Used in Traditional Chinese Medicine
(TCM) to promote the flow of qi (vital
energy)
49
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Oral
0QI-FL-PR-00-TCM
HC
Used in TCM to eliminate blood stasis, promote the
flow of qi and relieve pain of menstruation due to
blood stasis
Oral
0QI-PR-AG-00-TCM
HC
Used in TCM to augment the protective Qi and
stabilize the exterior: for deficiency with
spontaneous sweating (PPRC 2000, Bensky and
Gamble 1993)
Traditionally used in Ayurveda as
Rasayana (rejuvenative tonic)
Oral
0RA-00-US-00-TAY
HC
Traditionally used in Ayurveda as Rasayana
(rejuvenative tonic) (Sukh 2005, API 2001, Upton
2000)
Used as a sleep aid
Oral
0SL-00-AI-00-N00
HC
Used as a sleep aid (Soulairac and Lambinet 1977;
Wyatt et al. 1971).
52
Traditionally used in Ayurveda as a sleep
aid
Oral
0SL-00-AI-00-TAY
HC
Traditionally used in Ayurveda as a sleep aid
(Khare 2004, Upton 2000)
53
Traditionally used in herbal medicine as a
mild sedative and/or sleep aid
Oral
0SL-00-AI-00-THM
HC
Traditionally used in Herbal Medicine as a mild
sedative and/or sleep aid (hypnotic)
Traditionally used in herbal medicine as a
sleep aid
Oral
0SL-00-AI-00-TWH
HC
Traditionally used (in Western herbalism) as a
sleep aid (Ellingwood 1983; Felter and Lloyd 1983;
BHP 1983).
Helps to promote sleep
Oral
0SL-00-PR-HE-S00
HC
Helps to promote sleep / used as a sleep aid
50
51
54
55
Used in Traditional Chinese Medicine
(TCM) to augment the protective Qi (vital
energy) and stabilize the exterior: for
deficiency with spontaneous sweating
Label
disclaimers
Warning S
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 7 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
56
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used in herbal medicine as a
sleep aid to help promote sleep
Oral
0SL-00-PR-HE-THM
HC
Traditionally used in Herbal Medicine as a sleep aid
to help promote sleep
57
Traditionally used in herbal medicine as a
calmative and/or sleep aid
Oral
0SL-CA-AI-00-THM
HC
Traditionally used in Herbal Medicine as a
calmative and/or sleep aid
58
Traditionally used in herbal medicine as a
sleep aid (in cases of restlessness or
insomnia due to mental stress)
Oral
0SL-RI-AI-00-S00
HC
Traditionally used in Herbal Medicine as a sleep aid
(in cases of restlessness or insomnia due to mental
stress)
Traditionally used in herbal medicine as a
sleep aid (in cases of restlessness or
insomnia due to stress)
Oral
0SL-RI-AI-00-THM
HC
Traditionally used in Herbal Medicine as a sleep aid
(in cases of restlessness or insomnia due to stress)
Traditionally used in Traditional Chinese
Medicine (TCM) to support the healing of
minor sores
Topical
0SO-00-HE-PR-TCM
HC
Traditionally used in TCM to promote healing of
sores
59
60
61
Label
disclaimers
Herbal medicinal product in conditions in
which easy defaecation with soft stool is
desirable
Oral
0SS-00-US-00-NHM
EMA
Herbal medicinal product in conditions in which
easy defaecation with soft stool is desirable, e.g. In
cases of painful defaecation after rectal or anal
surgery, anal fissures or haemorrhoids
62
Improves stamina and endurance
Oral
0ST-00-IM-00-S00
SAN13
Improves stamina and endurance
63
Traditionally used in herbal medicine to
induce sweating
Oral
0SW-00-IN-00-T00
HC
Traditionally used to induce sweating (a
diaphoretic) (Hoffman 1996; Grieve 1971).
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 8 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
64
Traditionally used in herbal medicine to
induce sweating (diaphoretic)
65
Traditional herbal medicinal product for
relief of excessive sweating
66
Traditional herbal medicinal product for
management of small superficial wounds
67
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Oral
0SW-00-IN-00-THM
HC
Traditionally used in Herbal Medicine to induce
sweating (diaphoretic)
Warning S
required
Topical
0SW-EX-RE-00-THM
EMA
Traditional herbal medicinal product for relief of
excessive sweating
Warning S
required
Topical
0SW-SM-MG-00-THM
EMA
Traditional herbal medicinal product for treatment
of small superficial wounds
Helps in tissue formation
Oral
0TI-00-FO-HE-S00
HC
Helps in tissue formation
68
Used in Traditional Chinese Medicine
(TCM) to support tissue regeneration
Topical
0TI-00-RE-PR-TCM
HC
Traditionally used in TCM to promote tissue
regeneration
69
Used in herbal medicine as a nutritive
tonic
Oral
0TO-NU-US-00-NHM
HC
Used in Herbal Medicine as a nutritive tonic
70
Traditionally used in herbal medicine as a
nutritive tonic
Oral
0TO-NU-US-00-THM
HC
(Traditionally) used in Herbal Medicine as a
nutritive tonic
71
72
Traditionally used in Ayurveda to balance
aggravated Vata (nervine tonic, sedative)
Oral
0VA-AG-BA-00-TAY
HC
Traditionally used in Ayurveda to balance
aggravated Vata (nervine tonic, sedative) (Kapoor
2001, Khory and Katrak 1999, Nadkarni and
Nadkarni 1954)
Assists in the maintenance of general wellbeing
Oral
0WB-GE-MA-AI-S00
WELL
Aids, assists or helps in the maintenance or
improvement of general well-being.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 9 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
73
Used in Traditional Chinese Medicine
(TCM) to dispel wind-dampness
Warning S
required
Oral
0WD-00-DI-00-TCM
HC
Traditionally used in TCM to dispel winddampness (Long 1998, Bensky and Gamble 1993)
74
75
Traditionally used in herbal medicine to
aid in wound healing
Topical
0WH-00-AI-00-THM
HC
Traditionally used in Herbal Medicine to aid in
wound healing (Bradley 2006, Hoffmann 2003,
Ellingwood 1983[1919], Felter and Lloyd
1983[1898])
Helps in wound healing
Oral
0WH-00-HE-00-S00
HC
Helps in wound healing
76
77
Traditional used in herbal medicine as an
aid in the healing of mild sunburn
Topical
0WH-MI-AI-00-THM
EMA
Traditional herbal medicinal product for the
symptomatic treatment of minor inflammations of
the skin (such as sunburn) and as an aid in healing
of minor wounds
Traditionally used in herbal medicine to
assist in minor wound healing
Topical
0WH-MI-AS-00-THM
HC
Traditionally used in Herbal Medicine to assist in
minor would healing
Assists weight loss by suppression of
appetite in conjunction with (or as part of)
a kilojoule/calorie controlled eating plan
Additional
statement as
per guidelines
eg has not
been shown to
cause weight
loss
Oral
0WM-AP-SP-00-SWM
WGHT
May aid or assist weight loss by suppression of
appetite in conjunction with (or as part of) a
kilojoule/calorie controlled eating plan
To be used with a program of reduced
intake of dietary calories and increased
physical activity to help in weight
management by reducing carbohydrate
Additional
statement as
per guidelines
eg has not
Oral
0WM-CA-RD-00-SWM
HC
To be used with a program of reduced intake of
dietary calories and increased physical activity to
help in weight management by reducing
78
79
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 10 of 92
Therapeutic Goods Administration
Ref
No
80
81
82
83
84
Proposed permitted indication
Label
disclaimers
cravings
been shown to
cause weight
loss
Traditionally used in herbal medicine to
support elimination (alterative) via the
kidneys, skin and mucus membranes
Route of
admin
Target-QT-action-QAcontext
Source
carbohydrate cravings
Oral
0WP-AC-RE-HE-THM
HC
Traditionally used in Herbal Medicine as an
alterative to help remove accumulated waste
products via the kidneys, skin and mucus
membranes (Hoffmann 2003, Wren 1907)
Relieves diarrhoea
Warning
DIAR required
Oral
A09-00-RE-00-S00
DIAR2
Relief or treatment of diarrhoea
Traditionally used in herbal medicine to
help relieve diarrhoea
Warning
DIAR required
Oral
A09-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve diarrhoea
Assists in the management of diarrhoea
Warning
DIAR required
Oral
A09-00-MG-AS-S00
DIAR/1/2
Relief or treatment of diarrhoea
Used in herbal medicine as an astringent
and to help relieve diarrhoea
Warning
DIAR required
Oral
A09-AS-RE-HE-NHM
HC
(Traditionally) used in Herbal Medicine as an
astringent and to help relieve diarrhoea
Traditionally used in herbal medicine as
an astringent to help relieve diarrhoea
Warning
DIAR required
Oral
A09-AS-RE-HE-THM
HC
Traditionally used in Herbal Medicine as an
astringent and/or a demulcent to help relieve
diarrhoea (Wichtl 2004 , Williamson 2003 , Lust
1987 , BHP 1983 , Sayre 1917 )
Traditionally used in herbal medicine as a
demulcent to help relieve diarrhoea
Warning
DIAR required
Oral
A09-DE-RE-HE-THM
HC
Traditionally used in Herbal Medicine as an
astringent and/or a demulcent to help relieve
diarrhoea (Wichtl 2004 , Williamson 2003 , Lust
85
86
Source indication
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 11 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
1987 , BHP 1983 , Sayre 1917 )
87
Traditional herbal medicinal product for
symptom management of mild diarrhoea
Warning
DIAR required
Oral
A09-MI-MG-SY-THM
EMA
Traditional herbal medicinal product for
symptomatic treatment of mild diarrhoea
88
Helps to reduce the recurrence of cold
sores
Warning S
required
Oral
B00-RE-RD-HE-S00
HC
Helps to reduce the recurrence of herpes simplex
virus (HSV) infection (e.g. Cold sores)
Relieves the symptoms of cold sores
Warning S
required
Topical
B00-SY-RE-00-S00
CSOR/INF
EC1
Relief of the symptoms of cold sores/ For the
symptomatic relief of cold sores
90
Relief of the pain of medically diagnosed
shingles by topical application.
Warning S2
required
Topical
B02-PA-RE-00-STA
SHING1
Relief of the pain of shingles rash by topical
application.
91
Relief of the itching of medically diagnosed
shingles by topical application.
Warning S2
required
Topical
B02-IT-RE-00-STA
SHING2
Relief of the itching of shingles rash by topical
application.
Wart remover (Not Genital Warts)
Warning S
required
Topical
B07-00-RE-00-N00
HC
Wart remover (FDA 1990).
93
Relieves the symptoms associated with
warts (NOT GENITAL WARTS)
Warning S
required
Topical
B07-00-RE-SY-S00
INFEC3
For the symptomatic relief of warts (not genital
warts).
94
Traditionally used in herbal medicine to
help remove warts (NOT GENITAL
WARTS)
Warning S
required
Topical
B07-HF-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
remove warts on the hands and feet
Relief of tinea by topical application.
Warning S
Topical
B35-00-RE-00-S00
TINEA1
Relief of tinea by topical application.
89
92
95
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 12 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
required
96
Relieves the symptoms of superficial
fungal infections (topical)
Warning S
required
Topical
B35-FI-RE-00-S00
FUNG1
Relief or treatment of fungal infections by topical
application.
97
For the management of superficial fungal
infections (topical)
Warning S
required
Topical
B35-00-MG-00-S00
FUNG1
Relief or treatment of fungal infections by topical
application.
98
Used in herbal medicine to help relieve the
symptoms of superficial fungal infections
(topical)
Warning S
required
Topical
B35-SY-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve fungal
infections
Relieves the symptoms of athletes foot
Warning S
required
Topical
B35-SA-RE-00-S00
TINEA4
For the symptomatic relief of athlete's foot
Relieves the symptoms of tinea
Warning S
required
Topical
B35-SY-RE-00-S00
TINEA3
For symptomatic relief of tinea. .
For the management of tinea by topical
application.
Warning S
required
Topical
B35-TI-MG-00-S00
TINEA2
Treatment of tinea by topical application.
Helps expel worms
Warning S
required
Oral
B82-00-EX-HE-S00
WORM
Helps rid the body of worms.
103
Relieves the symptoms of scabies by
topical application
Warning S
required
Topical
B86-SY-RE-00-S00
SCAB
Relief of scabies by topical application.
104
Relieves the symptoms of papilloma (not
Warning S
Topical
B97?-SY-RE-00-S00
INFEC2
For the symptomatic relief of papillons (not genital
99
100
101
102
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 13 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
genital warts)
required
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
warts).
105
Helps to prevent dietary Vitamin B12
deficiency
Oral
D51-00-PV-HE-S00
HC
Helps to prevent Vitamin B12 deficiency
106
Assists blood circulation
Oral
DBL-CI-SU-00-S00
BLOOD1
May assist blood circulation
BLOOD2/F
OLIC1/2/I
RON1/VB1
21/VB122
Helps maintain normal blood/blood tonic (Note:
These claims are appropriate for folic acid, vitamin
B12 and iron, but must not imply anaemic
conditions)/ Source of folic acid. Can assist in
maintaining normal blood. Blood tonic/ Helps
maintain normal blood/blood tonic, Source of iron.
Can assist in maintaining normal blood, Source of
iron. Can assist in maintaining normal blood. Blood
tonic, Source of iron. Iron is necessary for the
formation of haemoglobin which transports oxygen
to the tissues/ Source of vitamin B12. Can assist in
maintaining normal blood. Blood tonic.
107
Used as a blood tonic to help maintain
normal blood
These claims
are
appropriate
for folic acid –
vitamin B12
and iron – but
must not
imply anaemic
conditions
Oral
DBL-NO-MA-AS-S00
108
109
Used as a blood tonic.
Oral
DBL-TO-US-00-S00
IRON2VB1
22
Helps maintain normal blood/blood tonic, Source
of iron. Can assist in maintaining normal blood,
Source of iron. Can assist in maintaining normal
blood. Blood tonic, Source of iron. Iron is necessary
for the formation of haemoglobin which transports
oxygen to the tissues.
Helps support immune system health after
periods of physical stress
Oral
DHE-PS-SU-HE-S00
HC
Helps support immune system health after periods
of physical stress
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 14 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
IRON5
Helps maintain normal blood/blood tonic, Source
of iron. Can assist in maintaining normal blood,
Source of iron. Can assist in maintaining normal
blood. Blood tonic, Source of iron. Iron is necessary
for the formation of haemoglobin which transports
oxygen to the tissues.
110
Necessary for the formation of
haemogloblin, which transports oxygen to
the tissues
Oral
DHG-00-FO-NE-S00
111
112
Helps to maintain immune function
Oral
DIM-FU-MA-HE-S00
HC
Source of vitamin A to help maintain immune
function/Provitamin A to help maintain immune
function/ Helps to maintain immune
function/Helps to maintain eyesight, skin
membranes and immune function
Used in herbal medicine to help maintain a
healthy immune system
Oral
DIM-HE-MA-HE-NHM
HC
Used in Herbal Medicine to help maintain a healthy
immune system
113
114
Traditionally used in herbal medicine to
support a healthy immune system
Oral
DIM-HE-MA-HE-THM
HC
Traditionally used in Herbal Medicine to help
maintain a healthy immune system (Bartram 1998,
Bensky and Gamble 1993, Grieve 1971[1931],
Assinewe 2001, Fulder 1993)
Supports a healthy immune system
Oral
DIM-HE-SU-00-S00
SAN09
Supports a healthy immune system
Helps to form red blood cells
Oral
DRC-00-FO-HE-S00
HC/FNFC
Helps to form red blood cells/A structural
component of vitamin B12 that helps form red
blood cells.
Helps proper function of red blood cells
Oral
DRC-00-PF-HE-S00
HC
Helps to form red blood cells and helps in their
proper function
115
116
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 15 of 92
Therapeutic Goods Administration
Ref
No
117
118
119
120
121
122
Proposed permitted indication
Label
disclaimers
Used in Traditional Chinese Medicine
(TCM) to benefit the spleen and lung
Used in Traditional Chinese Medicine
(TCM) to tonify the spleen and augment
the Qi (vital energy): for spleen deficiency
presenting with a lack of appetite, fatigue,
and diarrhoea
Warning S
required
Prevention of dietary vitamin [XX]
deficiency.
NS1
Prevention of dietary mineral [YY]
deficiency.
NS1
For the management of medically
confirmed vitamin [XX] deficiency (This
indication is not be to used for the
treatment of iron deficiency conditions).
NS1
For the management of medically
confirmed dietary mineral [YY] deficiency
(This indication is not be to used for the
treatment of iron deficiency conditions).
NS1
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Oral
DSL-00-BE-00-TCM
HC
Used in TCM to reinforce qi, benefit the spleen and
lung, relieve symptoms of thirst due to impairment
of body fluids and internal heat
HC
Used in Traditional Chinese Medicine (TCM) to
tonify the spleen and augment the Qi (vital energy):
for spleen deficiency presenting with a lack of
appetite, fatigue, and diarrhoea (PPRC 2000,
Bensky and Gamble 1993)
Oral
VIT1
Oral
Oral
E56-ND-PV-00-S00
Prevention/treatment of vitamin [XX] and/or
mineral [YY] and/or nutritional deficiencies (This
indication is not be to used for the treatment of
iron deficiency conditions).
E56-ND-PV-00-MIN
Prevention/treatment of vitamin [XX] and/or
mineral [YY] and/or nutritional deficiencies (This
indication is not be to used for the treatment of
iron deficiency conditions).
VIT1
Oral
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
DSP-00-TO-00-TCM
E56-ND-MG-00-S00
Prevention/treatment of vitamin [XX] and/or
mineral [YY] and/or nutritional deficiencies (This
indication is not be to used for the treatment of
iron deficiency conditions).
Page 16 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
123
Assists in the prevention of dietary iron
deficiency.
Warning NS1
124
Helps prevent symptoms of lactose
intolerance (including gas, bloating,
cramping and diarrhoea).
Warning S
required
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Oral
E61-ID-PV-AS-S00
IRON6
May assist in the management of dietary iron
deficiency.
Oral
E73-SY-PV-HE-S00
HC
Helps prevent symptoms of lactose intolerance
(including gas, bloating, cramping and diarrhea).
125
Assists in the maintenance of normal
blood fat levels in healthy individuals
Oral
EBF-NO-MA-AS-S00
BLDFAT01
May assist in the maintenance of normal blood
lipid/blood fat levels in healthy individuals
126
Assists in the maintenance of normal
blood lipid levels in healthy individuals
Oral
EBL-NO-MA-AS-S00
BLDFAT01
May assist in the maintenance of normal blood
lipid/blood fat levels in healthy individuals
Oral
ECA-00-AB-HE-S00
VITD
Vitamin D helps calcium absorption (or words of
like intent) and a diet deficient in calcium can lead
to osteoporosis in later life
127
Helps calcium absorption
VIT advisory
statement
required
128
Helps in the absorption and utilisation of
calcium
Oral
ECA-00-AU-HE-S00
HC
Helps in the absorption and use of calcium
129
Promotes calcium absorption
Oral
ECA-00-PR-00-S00
SAN06
Promotes calcium absorption
130
Promotes the intestinal absorption of
calcium
Oral
ECA-AB-PR-00-S00
FNFC
Promotes to absorb calcium in gut intestine
131
Helps the body to metabolize
carbohydrates
Oral
ECB-00-ME-HE-S00
HC
Helps the body to metabolize carbohydrates
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 17 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
132
Helps to reduce intestinal absorption of
cholesterol from dietary sources.
Warning CHL
required
Oral
ECH-IA-RD-HE-S00
CHOL05
May help to reduce intestinal absorption of
cholesterol from dietary sources.
133
Assists in the maintenance of
normal/healthy cholesterol levels in
healthy individuals.
Oral
ECH-NH-MA-AS-S00
CHOL02
May assist in the maintenance of normal/healthy
cholesterol levels in healthy individuals.
Assists in the maintenance of cholesterol
within the normal range in healthy
individuals.
Oral
ECH-NR-MA-AS-S00
CHOL01
May assist in the maintenance of cholesterol within
the normal range in healthy individuals.
134
135
136
137
Helps reduce the oxidation of LDL
cholesterol.
Warning CHL
required
Oral
ECH-OX-RD-HE-S00
CHOL06
May help reduce the oxidation of LDL cholesterol.
Assists in the improvement of the
LDL:HDL ratio.
Warning CHL
required
Oral
ECR-00-IM-AS-S00
CHOL03
May assist in the maintenance of cholesterol within
the normal/healthy range in healthy individuals
and improve the LDL:HDL ratio.
Assists in the maintenance of a
normal/healthy LDL:HDL cholesterol
ratio.
Warning CHL
required
Oral
ECR-NH-MG-AS-S00
CHOL04
May assist in the maintenance of a normal/healthy
LDL:HDL cholesterol ratio.
138
Helps the body to metabolise fats
Oral
EFA-00-ME-HE-S00
HC
Helps the body to metabolise fats
139
Aids the emulsification and/or digestion of
fats in the intestine
Oral
EFA-DI-AI-00-S00
DIG6
Aids digestion and helps to emulsify fats in the
digestive system.
140
Helps restore plasma glutamine levels
depleted after periods of physical stress
Oral
EGL-PS-RS-HE-S00
HC
Helps restore plasma glutamine levels depleted
after periods of physical stress (e.g. prolonged
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 18 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
(e.g. prolonged exhaustive exercise)
141
Provides support for healthy glucose
metabolism
142
143
Source indication
exhaustive exercise)
Warning BSL
required
Oral
EGM-HE-SU-PR-S00
HC
Provides support for healthy glucose metabolism
Helps in the absorption and utilisation of
phosphorus
Oral
EPH-00-AU-HE-S00
HC
Helps in the absorption and use of phosphorus
Helps the body to metabolise proteins
Oral
EPR-00-ME-HE-S00
HC
Helps the body to metabolise proteins
Helps the body to sythesize proteins
Oral
EPS-00-IN-00-S00
HC
A non-essential amino acid that is involved in
protein synthesis
145
Supports normal/healthy thyroid function
Oral
ETF-HE-SU-00-S00
BM08
Supports normal/healthy thyroid function
146
Helps in the function of the thyroid gland.
Oral
ETG-00-FU-HE-S00
HC
Helps in the function of the thyroid gland.
147
Assists in the maintenance of triglycerides
within the normal range in healthy
individuals.
Oral
ETG-NO-MA-AS-S00
BLTRIG01
May assist in the maintenance of triglycerides
within the normal range in healthy individuals.
Oral
F10-HO-MG-AS-S00
HANG2
May assist in the management of hangover
144
148
Assists in the management of hangover
The NHMRC
recommends
that for healthy
men and
women,
drinking no
more than two
standard
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 19 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Relieves the symptoms of hangover
The NHMRC
recommends
that for healthy
men and
women,
drinking no
more than two
standard
drinks on any
day reduces
the lifetime
risk of harm
from alcoholrelated disease
or injury.
Oral
F10-SY-RE-00-S00
HANG1
For symptomatic relief of hangover.
150
Relief of mood swings associated with
Premenstrual tension.
Warning S
required
Oral
F38-PT-RE-00-S00
NERV14
For the symptomatic relief of mood swings.
151
Relief of mood swings associated with
Menopause.
Warning S
required
Oral
F38-MP-RE-00-S00
NERV14
For the symptomatic relief of mood swings.
152
Assists in the management of mood
swings associated with Premenstrual
Warning S
Oral
F38-PT-MG-AS-S00
NERV17
May assist in the management of mood swings.
drinks on any
day reduces
the lifetime
risk of harm
from alcoholrelated disease
or injury.
149
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 20 of 92
Therapeutic Goods Administration
Proposed permitted indication
Label
disclaimers
tension.
required
153
Assists in the management of mood
swings associated with Menopause.
154
Ref
No
Route of
admin
Target-QT-action-QAcontext
Source
Warning S
required
Oral
F38-MP-MG-AS-S00
NERV17
Helps relieve mild anxiety.
Warning S
required
Oral
F41-00-RE-HE-S00
155
Relieves the symptoms of mild anxiety.
Warning S
required
Oral
F41-SY-RE-00-S00
156
Assists in the management of mild anxiety.
Warning S
required
Oral
F41-00-MG-AS-S00
157
Helps relieve stress.
Warning S
required
Oral
F43-00-RE-HE-S00
158
Relieves symptoms of stress
Warning S
required
Oral
159
Traditionally used in herbal medicine to
help relieve headaches
Warning S
required
160
Traditionally used in herbal medicine to
help ease (gastric) headaches
Relieves insomnia
161
Source indication
NERV1
Helps relieve nervous tension, stress and mild
anxiety.
NERV13
For the symptomatic relief of anxiety.
NERV16
May assist in the management of anxiety.
NERV1
Helps relieve nervous tension, stress and mild
anxiety.
F43-SY-RE-00-S00
NERV15/1
8
May assist in the management of stress disorders.
Oral
F51-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve headaches
Warning S
required
Oral
F51-GA-EA-HE-S00
HC
Traditionally used in Herbal Medicine to help ease
(gastric) headaches
Warning S
required
Oral
F51-IN-RE-00-S00
SLEEP2
Relief of insomnia.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 21 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Warning S
required
Oral
F51-SL-RE-00-S00
SLEEP1
Relief of sleeplessness.
Helps to enhance cognitive function in
adults
Oral
FCF-00-EN-HE-SAD
HC
Helps to enhance cognitive function in adults
Used in herbal medicine to help support
cognitive function
Oral
FCF-00-SU-HE-NHM
HC
(Used in Herbal Medicine to) help(s) support
cognitive function and/or reduce mental fatigue (in
cases of mental stress)
Helps to support cognitive function in
healthy people
Oral
FCF-00-SU-HE-S00
HC
Helps to support cognitive function
Helps support cognitive health
Oral
FCH-00-SU-HE-S00
HC
Helps support cognitive health and/or brain
function
167
Used in herbal medicine to help promote
healthy mood balance
Oral
FMB-HE-PR-HE-NHM
HC
(Used in Herbal Medicine to) help(s) promote
healthy mood balance
168
Helps to promote healthy mood balance
Oral
FMB-HE-PR-HE-S00
HC
Helps to promote healhy mood balance
169
Improve and maintain memory
Oral
FME-00-IM-00-S00
BM07
Improve/maintain memory and cognitive function
170
Helps to temporarily promote relaxation
Oral
FRE-00-PR-HE-S00
HC
Helps to temporarily promote relaxation
Oral
G43-00-MG-AS-S00
MIGR4
May assist in the management of migraine.
162
163
164
165
166
171
Relieves sleeplessness
Assists in the management of migraine
HS
Warning S
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 22 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
172
173
174
175
176
177
178
179
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditional herbal medicinal product for
the prophylaxis of migraine headaches
after serious conditions have been
excluded by a medical doctor
Oral
G43-00-PR-00-THM
EMA
Traditional herbal medicinal product for the
prophylaxis of migraine headaches after serious
conditions have been excluded by a medical doctor
Used in herbal medicine to help prevent
migraine headaches
Oral
G43-00-PV-HE-NHM
HC
Used in Herbal Medicine to help prevent migraine
headaches
Temporary relief of migraine headache.
Warning S
required
Oral
G43-00-RE-TE-S00
MIGR
Temporary relief of migraine headache.
Helps reduce the frequency of migraines.
Warning S
required
Oral
G43-FR-RD-00-S00
MIGR2
May help reduce the frequency of migraines.
Helps reduce the frequency of migraine
headaches and associated nausea and
vomiting when taken as a prophylactic
Warning S
required
Oral
G43-FR-RD-HE-SPR
HC
Helps to reduce the frequency of migraine
headaches and associated nausea and vomiting
when taken as a prophylactic
Helps reduce the severity and duration of
migraine headaches when taken as a
prophylactic
Warning S
required
Oral
G43-SD-RD-HE-SPR
HC
Helps to reduce the severity and duration of
migraine headaches when taken as a prophylactic
Used in herbal medicine to help reduce the
severity and/or frequency of migraine
headaches and associated symptoms such
as nausea and vomiting, when taken as a
prophylactic
Warning S
required
Oral
G43-SF-RD-HE-NPR
HC
Used in Herbal Medicine to help reduce the
severity and/or frequency of migraine headaches
and associated symptoms such as nausea and
vomiting, when taken as a prophylactic
Relieves the symptoms of tension
Warning S
Oral
G44-SY-RE-00-S00
MIGR3
For the symptomatic relief of tension headache.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 23 of 92
Therapeutic Goods Administration
Proposed permitted indication
Label
disclaimers
headache
required
180
Assists in the management of tension
headache
181
Ref
No
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Warning S
required
Oral
G44-TH-MG-AS-S00
MIGR5
May assist in the management of tension headache.
Temporary relief of neuralgic headache.
Warning S
required
Oral
G44-NE-RE-TE-S00
HEAD2
Temporary relief of neuralgic headache.
182
Herbal medicinal product for the relief of
sleep disorders
Warning S
required
Oral
G47-00-RE-00-NHM
EMA
Herbal medicinal product for the relief of sleep
disorders
183
Used in herbal medicine to help relieve
sleep disturbances associated with mild
anxiety
Warning S
required
Oral
G47-MI-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve sleep
disturbances associated with mood imbalance
Sublingual/
Oral
G47-SL-RD-HE-S00
HC
Helps to reduce the time it takes to fall asleep
(sleep onset latency aspect of sleep quality) in
people with delayed sleep phase syndrome
184
Helps to reduce the time it takes to fall
asleep (sleep onset latency aspect of sleep
quality) in people with delayed sleep
phase syndrome
185
Relieves the symptoms of medically
diagnosed carpal tunnel syndrome
Warning S2
required
Oral
G56-SY-RE-00-S00
186
Assists in the management of medically
diagnosed carpal tunnel syndrome
Warning S2
required
Oral
G56-00-MG-AS-S00
187
Relieves the symptoms of medically
diagnosed chronic fatigue syndrome.
Warning S2
required
Oral
G93-SY-RE-00-S00
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
CTS1
For the symptomatic relief of medically diagnosed
carpal tunnel syndrome
CTS2
May assist in the management of medically
diagnosed carpal tunnel syndrome
CFS1
For the symptomatic relief of chronic fatigue
syndrome.
Page 24 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
188
Assists in the management of medically
diagnosed chronic fatigue syndrome.
Warning S2
required
Oral
G93-00-MG-AS-S00
189
Helps support the development of the
brain in children up to 12 years of age
Oral
GBR-00-DE-SU-SCH
HC
Helps support the development of the brain, eyes
and nerves in children up to 12 years of age
Helps support brain function
Oral
GBR-FU-SU-HE-S00
HC
Helps support cognitive health and/or brain
function
191
Supports healthy functioning of the
nervous system
Oral
GFU-HE-SU-00-S00
BM03
Supports healthy functioning of the nervous system
192
Helps support the development of the
nerves in children up to 12 years of age
Oral
GNE-00-DE-SU-SCH
HC
Helps support the development of the brain, eyes
and nerves in children up to 12 years of age
193
Helps re-set the body's sleep-wake cycle
(aspect of the circadian rhythm)
Sublingual/
Oral
GSC-CR-RT-HE-S00
HC
Helps re-set the body's sleep-wake cycle (aspect of
the circadian rhythm)
194
Helps increase the total sleep time (aspect
of sleep quality) in people suffering from
sleep restriction or altered sleep schedule ,
e.g. Shift work and jet lag
Sublingual/
Oral
GST-TO-IN-HE-SSW
HC
Helps increase the total sleep time (aspect of sleep
quality) in people suffering from sleep restriction
or altered sleep schedule , e.g. Shift work and jet lag
195
Assists visual fatigue and eye-strain
Ophthalmic
H53-00-AS-00-S00
EYE1
Eyes formula. Assists visual fatigue and eye-strain
196
Helps eyes adapt to variations in light
intensity
Ophthalmic
H53-LI-AD-HE-S00
EYE3
Eyes formula. Helps eyes to adapt to variations in
light intensity.
190
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Source
Source indication
CFS2
May assist in the management of chronic fatigue
syndrome.
Page 25 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
197
Relieves the symptoms of tinnitus
Warning S
required
Oral
H93-SY-RE-00-S00
198
Assists in the management of tinnitus
Warning S
required
Oral
H93-00-MG-AS-S00
199
Traditionally used in herbal medicine for
the temporary relief of eye discomfort due
to dryness of the eye or to exposure to
wind or sun
Warning S
required
Ophthalmic
HDI-00-RE-TE-THM
Source
Source indication
EAR3
For the symptomatic relief of tinnitus.
EAR6
May assist in the management of tinnitus.
HC/EMA
Traditional herbal medicinal product/Traditionally
used in Herbal Medicine for the temporary relief of
eye discomfort due to dryness of the eye or to
exposure to wind or sun
200
201
202
203
204
Helps to maintain eyesight
Oral
HES-00-MA-HE-S00
HC
Helps to maintain eyesight/Provitamin A to help
maintain eyesight/Source of vitamin A to help
maintain eyesight/Helps to maintain eyesight, skin
membranes and immune function
Helps support the development of the eyes
in children up to 12 years of age
Oral
HEY-00-DE-SU-SCH
HC
Helps support the development of the brain, eyes
and nerves in children up to 12 years of age
Helps maintain healthy eyes
Oral
HEY-HE-MA-HE-S00
EYE5/SAN
14
Maintenance of healthy eyes/Helps maintain
healthy eyes
HEY-HE-SU-00-S00
SAN14
Helps maintain healthy eyes
HEY-SI-RE-00-S00
EYE6
Maintenance of healthy eyes. Provides relief from
superficial eye problems such as sore - red and
inflamed eyes
Supports eye health
Relief of the soreness and inflammation
associated with minor eye conditions
Warning S
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Ophthalmic
Page 26 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
205
Assists in the management of watery or
itchy eyes
Warning S
required
Ophthalmic
HEY-WI-MG-AS-S00
EYE9
May assist in the management of watery or itchy
eyes.
Relieves watery or itchy eyes
Warning S
required
Ophthalmic
HEY-WI-RE-00-S00
EYE7
For the symptomatic relief of watery or itchy eyes
Ophthalmic
HFU-EY-SU-00-S00
EYE2
Eyes formula. Support of healthy eye function
206
207
Supports healthy eye function
208
209
Helps in the development and
maintenance of night vision
Oral
HVI-NI-DM-HE-S00
HC
Provitamin A/Source of vitamin A to help in the
development and maintenance of night
vision/Helps in the development and maintenance
of night vision
Involved in rod vision
Ophthalmic
HVI-RO-IN-00-S00
EYE4
Eyes formula. Has a specific role in rod vision.
HC
Traditionally used as an astringent to relieve
symptoms of haemorrhoids, damaged veins
(varicose veins), bruises and localized inflamed
swellings. (Jellin et al. 2003; Bisset and Wichtl
2001; Blumenthal et al. 2000; Foster 1998;
Moerman 1998; Chevallier 1996; Leung and Foster
1996).
210
Traditionally used in herbal medicine as
an astringent to relieve symptoms of
damaged veins
Warning S
required
Oral
I83-AS-RE-00-THM
211
Relieves aching legs associated with
varicose veins.
Warning S
required
Oral
I83-AL-RE-00-S00
212
Assists in the management of varicose
veins.
Warning S
required
Oral
I83-00-MG-AS-S00
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
VEIN1
Relieves aching legs associated with enlarged or
varicose veins.
VEIN2
May assist in the management of varicose veins.
Page 27 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
213
Temporary relief of the symptoms of
varicose veins.
Warning S
required
Oral
I83-SY-RE-TE-S00
214
Helps relieve swelling, heaviness, pain and
itching of the legs associated with varicose
veins
Warning S
required
Topical
I83?-SY-RE-00-S00
Topical
I84-DI-RE-00-S00
Oral
I84-SM-MG-AS-S00
215
216
217
218
Relief of the discomfort of medically
diagnosed haemorrhoids by local
application.
Warning S2
required
Assists in the management of medically
diagnosed haemorrhoids by softening
bowel motions
Warnings S2
AND LAX1
required
Herbal medicinal product for the
management of medically diagnosed
chronic venous insufficiency, which is
characterised by swollen legs, varicose
veins, a feeling of heaviness, pain,
tiredness, itching, tension and cramps in
the calves
Used in herbal medicine to help relieve
symptoms related to non-complicated
medically diagnosed chronic venous
insufficiency (CVI), such as sensation of
swelling, heaviness and tingling of the legs
Warning S2
required
Warning S2
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Oral
Oral
I87-00-MG-00-NHM
I87-SY-RE-HE-NHM
Source
Source indication
VEIN3
Short-term symptomatic treatment of varicose
veins.
BM14
Helps relieve swelling, heaviness, pain and itching
of the legs
HAEM1
Relief of the discomfort of haemorrhoids by local
application.
HAEM2
Bulk laxative of indirect benefit to people suffering
from haemorrhoids.
EMA
Herbal medicinal product for treatment of chronic
venous insufficiency, which is characterised by
swollen legs, varicose veins, a feeling of heaviness,
pain, tiredness, itching, tension and cramps in the
calves
HC
Used in Herbal Medicine to help relieve symptoms
related to non-complicated chronic venous
insufficiency (CVI), such as sensation of swelling,
heaviness and tingling of the legs (Barnes et al.
2007, Mills and Bone 2005, ESCOP 2003, Upton
2001)
Page 28 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
219
Helps to relieve symptoms related to noncomplicated medically diagnosed chronic
venous insufficiency (CVI), such as
sensation of swelling, heaviness and
tingling of the legs
Warning S2
required
Oral
Used in herbal medicine to help manage
medically diagnosed chronic venous
insufficiency and associated symptoms
Warning S2
required
220
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
I87-SY-RE-HE-S00
HC
Helps to relieve symptoms related to noncomplicated chronic venous insufficiency (CVI),
such as sensation of swelling, heaviness and
tingling of the legs
Oral
I87-SY-MG-HE-NHM
HC
Used in Herbal Medicine to help treat chronic
venous insufficiency and associated symptoms
221
Helps to support healthy arteries
Oral
IAR-HE-SU-HE-S00
BM09
Helps maintain healthy arteries
222
Maintains proper blood circulation
Oral
IBC-PR-MA-00-S00
FNFC
Maintains proper blood circulation
Used in Traditional Chinese Medicine
(TCM) to eliminate blood stasis
Oral
IBL-BS-EL-00-TCM
HC
Used in TCM to eliminate blood stasis, promote the
flow of qi and relieve pain of menstruation due to
blood stasis
224
Assists in the maintenance of normal
blood pressure in healthy individuals.
Oral
IBP-NO-MA-AS-S00
BLOODP01
May assist in the maintenance of normal blood
pressure in healthy individuals.
225
Help to support normal blood pressure in
healthy individuals.
Oral
IBP-NO-SU-HE-S00
BLOODP02
May help to support normal blood pressure in
healthy individuals.
226
Protects the integrity of capillary walls
Oral
ICA-IN-PT-00-S00
BLOOD3
Protects capillaries
227
Protects capillaries from oxidating agents
Oral
ICA-OA-PT-00-S00
BLOOD3
Protects capillaries
223
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 29 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
228
Helps maintain healthy capillaries
229
Traditional herbal medicinal product to
relieve symptoms of discomfort and
heaviness of legs related to minor venous
circulatory disturbances such as varicose
veins
230
Assists peripheral circulation
231
Assists in the maintenance of peripheral
circulation to relieve cold hands and feet.
232
Helps maintain blood circulation to the
peripheral areas of the body such as the
legs, hands and feet
233
Traditional herbal medicinal product
[used] as an adjuvant in the relief of minor
peripheral circulatory disorders
Label
disclaimers
Warning S
required
Warning S
required
Warning S
required
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Oral
ICA-HE-MA-HE-S00
BLOOD4
Maintain health of capillaries
Oral/Topical
ICD-DH-RE-00-THM
EMA
Traditional herbal medicinal product to relieve
symptoms of discomfort and heaviness of legs
related to minor venous circulatory disturbances
Oral
ICI-PE-AS-00-S00
BLOOD7
May assist peripheral circulation.
Oral/Topical
ICI-PE-MA-AA-S00
PERI1/2/3
Aids or assists in the maintenance of peripheral
circulation to relieve cold hands and feet.
Oral/Topical
ICI-PE-MA-HE-S00
BLOOD5/6
To help maintain blood circulation to the
peripheral areas of the body such as the legs,
hands and feet.
Topical
ICI-PE-RE-AD-THM
EMA
Traditional herbal medicinal product as an
adjuvant in the relief of minor muscular and
articular pain and in minor peripheral circulatory
disorders
234
Helps to support healthy peripheral
circulation
Oral/Topical
ICI-PE-SU-HE-S00
HC
Helps to support peripheral circulation
235
Traditionally used in herbal medicine to
help support peripheral circulation
Oral
ICI-PE-SU-HE-THM
HC
Traditionally used in Herbal Medicine to help
support peripheral circulation
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 30 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
236
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Helps to support the cardiovascular
system
Oral
ICV-FU-SU-HE-S00
HC
Helps to support cardiovascular function
237
Used in herbal medicine to help maintain
cardiovascular health in adults
Oral
ICV-HE-MA-HE-NHA
HC
Used in herbal medicine to help maintain
cardiovascular health in adults
238
Helps maintain cardiovascular health
Oral
ICV-HE-MA-HE-S00
HC
Helps maintain/support cardiovascular health
239
Traditionally used in herbal medicine to
help maintain cardiovascular health in
adults
Oral
ICV-HE-MA-HE-THA
HC
Traditionally used in Herbal Medicine to help
maintain and/or support cardiovascular health in
adults
240
Used in herbal medicine to help support
cardiovascular health in adults
Oral
ICV-HE-SU-HE-NHA
HC
Used in Herbal Medicine to help maintain and/or
support cardiovascular health in adults
241
Helps support cardiovascular health
Oral
ICV-HE-SU-HE-S00
HC
Helps maintain/support cardiovascular health
242
Traditionally used in herbal medicine to
help support cardiovascular health in
adults
Oral
ICV-HE-SU-HE-THA
HC
Traditionally used in Herbal Medicine to help
maintain and/or support cardiovascular health in
adults
Helps support a modest improvement in
exercise capacity in individuals with stable
cardiovascular diseases (CVD)
Oral
IEC-MO-SU-HE-SCV
HC
May help support a modest improvement in
exercise capacity in individuals with stable
cardiovascular diseases (CVD)
Oral
J00-00-FO-HE-NHM
HC
Used in Herbal medicine to help fight off infections,
especially of the upper respiratory tract
243
244
Used in herbal medicine to help in the
management of mild upper respiratory
tract infections
Label
disclaimers
Warnings S &
COLD
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 31 of 92
Therapeutic Goods Administration
Ref
No
245
246
247
248
249
250
251
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Assists in the management of mild upper
respiratory tract infections
Warnings S &
COLD
required
Oral
J00-MI-MG-AS-S00
COLD10
May assist in the management of upper respiratory
tract infections
Traditionally used in herbal medicine to
help relieve minor inflammation of the
mucous membranes of the mouth/throat
Warnings S &
COLD
required
Oral
J00-00-RE-HE-THM
HC
(Traditionally) used in Herbal Medicine to help
relieve mucous membrane inflammations of the
mouth and/or throat
Helps to shorten the duration of upper
respiratory tract infections (e.g. common
cold)
Warnings S &
COLD
required
Oral
J00-00-SH-HE-S00
HC
Helps to relieve the symptoms and shorten the
duration of upper respiratory tract infections (e.g.
common cold)
Supportive therapy in the management of
mild upper respiratory tract infections
(e.g. Common colds)
Warnings S &
COLD
required
Oral
J00-00-MG-SU-S00
HC
Supportive therapy in the treatment of upper
respiratory tract infections (e.g. Common colds)
Traditional herbal medicinal product for
supportive management of common cold
Warnings S &
COLD
required
Oral
J00-00-MG-SU-THM
EMA
Traditional herbal medicinal product for
supportive treatment of common cold
Herbal medicinal product traditionally
used to relieve symptoms of sore throat
associated with dry cough and cold
Warning S,
COLD, COU1 &
COU2
required
Oral
J00-CC-RE-00-NHM
EMA
Herbal medicinal product traditionally used to
relieve symptoms of sore throat associated with
dry cough and cold
Traditionally used in herbal medicine to
help relieve coughs and irritation of the
throat in colds and catarrh of the
respiratory tract
Warning S,
COLD, COU1 &
COU2
required
Oral
J00-CI-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve coughs and irritation of the throat in colds
and catarrh of the respiratory tract (Wichtl 2004 ,
Blumenthal et al. 2000 , Bradley 1992 , Felter and
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 32 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Lloyd 1983[1898] )
252
253
254
Helps reduce the duration of colds
Warnings S &
COLD
required
Oral
J00-DR-RD-00-S00
COLD5
May reduce the duration of colds
Herbal medicinal product traditionally
used for the relief of early symptoms of
the common cold
Warnings S &
COLD
required
Oral
J00-ES-RE-00-THM
EMA
Herbal medicinal product traditionally used for the
relief of early symptoms of common cold
Helps reduce the frequency of common
colds
Warnings S &
COLD
required
Oral
J00-FR-RD-HE-S00
SAN11
May help reduce the frequency of common cold
Warnings S &
COLD
required
Oral
J00-IN-RE-00-S00
COLD9
For the symptomatic relief of upper respiratory
tract infections.
Helps reduce the severity and duration of
colds
Warnings S &
COLD
required
Oral
J00-SD-RD-00-S00
COLD6
May reduce the severity and duration of colds
Helps reduce the severity of colds
Warnings S &
COLD
required
Oral
J00-SV-RD-00-S00
COLD4
May reduce severity of colds
Warnings S &
COLD
required
Oral
J00-SV-RD-HE-S00
COLD2
May help reduce the severity of the symptoms of
colds.
255
Relieves the symptoms of mild upper
respiratory tract infections.
256
257
258
Helps reduce the severity of the symptoms
of colds.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 33 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Warnings S &
COLD
required
Oral
J00-SY-RE-00-S00
COLD1
Traditional herbal medicinal product for
the relief of symptoms in coughs and colds
Warning S,
COLD, COU1 &
COU2
required
Cutaneous
J00-SY-RE-00-THM
EMA
Traditional herbal medicinal product for the relief
of symptoms in coughs and colds
Helps to relieve the symptoms of mild
upper respiratory tract infections (e.g.
common cold)
Warning S &
COLD
required
Oral
J00-SY-RE-HE-S00
HC
Helps to relieve the symptoms and shorten the
duration of upper respiratory tract infections (e.g.
common cold)
Traditionally used in herbal medicine to
help relieve cold symptoms
Warning S &
COLD
required
Oral
J00-SY-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve cold symptoms (Blumenthal et al. 2000,
Moerman 1998)
Warnings S
and COLD
required
FLU5
Treatment of colds/flu.
Oral
J00-00-MG-AS-S00
Assists in the management of sinusitis
Warning S
required
Oral
J01-00-MG-AS-S00
SINUS4
May assist in the management of sinusitis.
Relieves sinus pain
Warning S
required
Oral
J01-PA-RE-00-S00
SINUS2
Relief of sinus pain.
Relieves the symptoms of sinusitis
Warning S
required
Oral
J01-SY-RE-00-S00
SINUS1/3
Relief of sinusitis. /For the symptomatic relief of
sinusitis
259
Relieves the symptoms of colds.
260
261
262
263
264
265
266
Assists in the management of colds
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Source indication
Relief of the symptoms of colds.
Page 34 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
267
Assists in the management of acute
pharyngitis/sore throat
Warning S
required
Oral
J02-00-MG-AS-S00
THROA2
May assist in the management of sore throat.
268
Temporary relief of cough and sore throat
by relaxing the cough reflex
Warning S
required
Oral
J02-SY-RE-TE-S00
COU3
Temporary relief of cough and sore throat.
Sedating action on the coughing reflex
Traditionally used in herbal medicine to
help relieve sore throat
Warning S
required
Oral/Buccal
J02-00-RE-HE-THM
HC
(Traditionally) used in Herbal Medicine to help
relieve sore throat and/or other mouth and throat
infections (PPRC 2005; Castalado and Capasso
2002; Mills and Bone 2000; Tilgner 1999).
Traditionally used in herbal medicine as
an astringent to help relieve sore throats
Warning S
required
Oral
J02-AS-RE-HE-THM
HC
Traditionally used in Herbal Medicine (as an
astringent) to help relieve sore throats
Traditionally used in herbal medicine as a
demulcent to help relieve sore throat
Warning S
required
HC
Traditionally used in Herbal Medicine as a
demulcent to help relieve sore throat (Williamson
2003 , Bisset and Wichtl 2001 , BHP 1983 , Sayre
1917 )
Traditional herbal medicinal product for
use as a demulcent preparation for the
relief of symptoms of oral or pharyngeal
irritation and associated dry cough
Warning S,
COU1 & COU2
required
Oral
J02-DE-RE-SY-THM
EMA
Traditional herbal medicinal product for use as a
demulcent preparation for the symptomatic
treatment of oral or pharyngeal irritation and
associated dry cough
Used in herbal medicine to help relieve
mild inflammations of the mucous
membranes of the mouth and/or throat
Warning S
required
Buccal
J02-MI-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve mild
inflammations of the mucous membranes of the
mouth and/or throat
Traditional herbal medicinal product for
Warning S
Topical/Oro
J02-MT-RE-SY-THM
EMA
Traditional herbal medicinal product for the
269
270
271
272
273
274
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Oral
J02-DE-RE-HE-THM
Page 35 of 92
Therapeutic Goods Administration
Proposed permitted indication
Label
disclaimers
Route of
admin
the relief of symptoms of minor
inflammations in the mouth or throat
required
mucosal
Relieves the symptoms of sore throat
Warning S
required
Oral
J02-SY-RE-00-S00
276
Relieves the symptoms of medically
diagnosed tonsillitis.
Warning S2
required
Oral
J03-SY-RE-00-S00
277
Relief of the pain of medically diagnosed
tonsillitis.
Warning S2
required
Oral
J03-PA-RE-00-S00
278
Relieves the discomfort of medically
diagnosed tonsillitis.
Warning S2
required
Oral
J03-DI-RE-00-S00
279
Relief of the discomfort associated with
laryngitis.
Warning S
required
Oral
280
Relief of the inflammation associated with
laryngitis.
Warning S
required
281
Relief of the pain associated with
laryngitis.
282
Ref
No
275
283
Target-QT-action-QAcontext
Source
Source indication
symptomatic treatment of minor inflammations in
the mouth or throat
THROA1
For the symptomatic relief of sore throat
TONS1
Relief of the symptoms associated with tonsillitis.
TONS3
Relief of the pain associated with tonsillitis.
TONS4
Relief of the discomfort associated with tonsillitis.
J04-DI-RE-00-S00
LARYN4
Relief of the discomfort associated with laryngitis.
Oral
J04-IN-RE-00-S00
LARYN2
Relief of the inflammation associated with
laryngitis.
Warning S
required
Oral
J04-PA-RE-00-S00
LARYN3
Relief of the pain associated with laryngitis.
Relieves the symptoms associated with
laryngitis.
Warning S
required
Oral
J04-SY-RE-00-S00
LARYN1
Relief of the symptoms associated with laryngitis.
Helps shorten the duration of mild upper
Warnings S &
COLD
Oral
J06-DU-RD-HE-S00
HC
Helps to relieve the symptoms and shorten the
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 36 of 92
Therapeutic Goods Administration
Ref
No
284
285
286
287
288
289
290
Proposed permitted indication
Label
disclaimers
respiratory tract infections
required
For the management of mild upper
respiratory tract infections
Warnings S &
COLD
required
Oral
J06-IN-MG-00-S00
RESP2/3
Helps fight mild upper respiratory complaints,
Treatment of upper respiratory tract infections
Relieves the symptoms of mild upper
respiratory tract infections (e.g., common
cold)
Warnings S &
COLD
required
Oral
J06-MI-RE-00-S00
RESP1
Relief of symptoms of mild upper respiratory
infections
Assists in the management of the
symptoms of mild infections of upper
respiratory tract
Warnings S &
COLD
required
Oral
J06-SY-MG-AS-S00
RESP4
Treatment of symptoms of mild infections of upper
respiratory tract
Relieves the symptoms of recurrent mild
upper respiratory tract infections
Warnings S &
COLD
required
Oral
J06-SY-RE-00-S00
RESP5
For the symptomatic relief of recurrent upper
respiratory tract infections
Helps to relieve the symptoms of mild
upper respiratory tract infections
Warnings S &
COLD
required
Oral
J06-SY-RE-HE-S00
HC
Helps to relieve the symptoms and shorten the
duration of upper respiratory tract infections
Traditionally used in herbal medicine to
help relieve the symptoms associated with
mild upper respiratory tract infections
and catarrhal conditions
Warning S &
COLD
required
Oral
J06-SY-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve the symptoms associated with upper
respiratory tract infections and catarrhal
conditions
Warnings S
and COLD
Oral
J11-SY-RE-00-S00
FLU1
Relief of the symptoms of influenza/flu.
Relieves the symptoms of colds and flu.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
duration of upper respiratory tract infections
Page 37 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
FLU2
Can assist in the treatment of flu by reducing the
severity and duration of symptoms.
FLU3
Relief of the pain of influenza/flu.
FLU4
Relief of the fever of influenza/flu.
FLU5
Treatment of colds/flu.
required
291
292
293
294
295
296
297
298
Assist in the management of colds and flu
(by reducing the severity and duration of
symptoms).
Warnings S
and COLD
required
Oral
J11-SD-MG-AS-S00
Relief of the pain of colds and flu.
Warnings S
and COLD
required
Oral
J11-PA-RE-00-S00
Warnings S
and COLD
required
Oral
J11-FE-RE-00-S00
Warnings S
and COLD
required
Oral
J11-00-MG-AS-S00
Assists in the management of rhinitis
Warning S
required
Oronasal
J30-00-MG-AS-S00
ALLER4
May assist in the management of rhinitis
Used in herbal medicine to help relieve
seasonal allergy symptoms
Warning S
required
Oral
J30-SY-RE-00-NHM
HC
Used in Herbal Medicine to help relieve seasonal
allergy symptoms (Mills and Bone 2005 , Tilgner
1999 )
Relieves the symptoms of hayfever
Warning S
required
Oronasal
J30-SY-RE-00-S00
HAYF
Relief of the symptoms of hayfever
Relieves the symptoms of rhinitis
Warning S
Oronasal
J31-SY-RE-00-S00
ALLER2
For the symptomatic relief of rhinitis
Relief of the fever of colds and flu.
Assists in the management of colds and
flu.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 38 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
required
299
Relieves the symptoms of catarrh
Warning S
required
Oral
JCA-SY-RE-00-S00
CATAR
Relieves the symptoms of coughs and
colds
Warning S,
COLD, COU1 &
COU2
required
Topical
JCC-SY-RE-00-S00
EMA
For the relief of symptoms in coughs and colds
Used in herbal medicine to help relieve
minor inflammation and/or irritation of
the mucous membranes of the mouth
and/or throat
Warning S
required
Buccal
JII-MI-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve minor
inflammation and/or irritation of the mucous
membranes of the mouth and/or throat (ESCOP
2003, Blumenthal et al. 2000, Bradley 1992)
Assists in the management of mild upper
respiratory tract infections (e.g., common
cold)
Warning S &
COLD
required
Oral
JIN-MI-MG-AS-S00
RESP6
May assist in the management of recurrent upper
respiratory tract infections
Used in Traditional Chinese Medicine
(TCM) to tonify the lungs and for frequent
colds
Warning S &
COLD
required
Oral
JLU-00-TO-00-TCM
HC
Used in TCM to tonify the lungs and for frequent
colds (PRC 1998, Bensky and Gamble 1993)
304
Used as a decongestant to relieve nasal
congestion
Warning S
required
Oral
JNC-00-RE-00-N00
HC
Used as a decongestant to relieve nasal congestion
305
Used in herbal medicine as a
decongestant/to relieve nasal congestion
Warning S
required
Oral
JNC-00-RE-00-NHM
HC
Used in Herbal Medicine as a decongestant/to
relieve nasal congestion
300
301
302
303
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Relief of the symptoms of catarrh.
Page 39 of 92
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Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
306
Relieves mucous congestion by drying the
secretion of the nose (decongestant)
Warning S
required
Nasal
JNC-00-RE-00-S00
NASAL
By drying the secretions of the nose, this nasal
decongestant product makes breathing easier. .
Relieves mucous congestion
Warning S &
COLD
required
Oral
JNC-CC-RD-00-S00
COLD7/M
UC
For relief of mucous congestion / Relief of mucous
congestion.
Used as a decongestant to relieve nasal
congestion (due to the common cold)
Warning S &
COLD
required
Oral
JNC-CC-RE-00-N00
HC
Used as a decongestant to relieve nasal congestion
(due to the common cold)
Used in herbal medicine as a decongestant
to relieve nasal congestion (due to the
common cold)
Warning S &
COLD
required
Oral
JNC-CC-RE-00-NHM
HC
Used in Herbal Medicine as a decongestant to
relieve nasal congestion (due to the common cold)
Used to relieve nasal congestion (due to
the common cold)
Warning S &
COLD
required
Oral
JNC-CC-RE-00-S00
HC
Used to relieve nasal congestion (due to the
common cold)
Used as a decongestant to relieve
symptoms of a chest cold
Warning S &
COLD
required
Oral
JNC-DE-US-00-S00
HC
Used as a decongestant (due to the common cold)
Used as a decongestant to relieve nasal
congestion (due to hay fever/allergic
rhinitis/allergies)
Warning S &
COLD
required
Oral
JNC-HF-RE-00-N00
HC
Used as a decongestant to relieve nasal congestion
(due to hay fever/allergic rhinitis/allergies)
Used in herbal medicine as a decongestant
to relieve nasal congestion (due to hay
Warning S &
COLD
Oral
JNC-HF-RE-00-NHM
HC
Used in Herbal Medicine as a decongestant to
relieve nasal congestion (due to hay fever/allergic
307
308
309
310
311
312
313
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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314
315
Proposed permitted indication
Label
disclaimers
fever/allergic rhinitis/allergies)
required
Used as a decongestant to relieve nasal
congestion (due to sinusitis)
Warning S &
COLD
required
Oral
JNC-SI-RE-00-N00
HC
Used as a decongestant to relieve nasal congestion
(due to sinusitis)
Used in herbal medicine as a decongestant
to relieve nasal congestion (due to
sinusitis)
Warning S &
COLD
required
Oral
JNC-SI-RE-00-NHM
HC
Used in Herbal Medicine as a decongestant to
relieve nasal congestion (due to sinusitis)
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
rhinitis/allergies)
316
Traditionally used in Herbal Medicine to
support the respiratory system
Oral
JRS-00-SN-00-T00
HC
Traditionally used to strengthen the respiratory
system (a pectoral) (Hoffman 1996; Grieve 1971).
317
Assists in the prevention of dental caries
Buccal
K02-00-PV-AS-S00
DENT7
May help prevent dental caries
318
Helps prevent tooth decay
Buccal
K02-00-PV-HE-S00
DECAY
For the prevention of tooth decay
319
Traditional herbal medicinal product for
the temporary relief of toothache due to a
dental cavity
Dental
K02-TO-RE-TE-THM
EMA
Traditional herbal medicinal product for the
temporary relief of toothache due to a dental cavity
320
321
Warning S
required
Relieves the symptoms of
temporomandibular joint disorder
diagnosed by a dentist or medical
practitioner.
Warning S
required
Assists in the management of
temporomandibular joint disorder
diagnosed by a dentist or medical
Warning S
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Oral
K07-SY-RE-00-S00
Oral
K07-00-MG-AS-S00
DENT2
For the symptomatic relief of temporomandibular
joint disorder.
DENT5
May assist in the management of
temporomandibular joint disorder.
Page 41 of 92
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No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Assists in the management of mouth
(aphthous) ulcers
Warning S
required
Oromucosal
K12-00-MG-AS-S00
DENT6
May assist in the management of aphthous ulcers
Traditionally used in herbal medicine to
help relieve mild irritations of the mucous
membranes of the mouth or throat
Warning S
required
HC
Traditionally used in Herbal Medicine to help
relieve mild irritations of the mucous membranes
of the mouth (Hoffmann 1996 , Grieve 1971[1931] ,
Wren 1907 , Meyrick 1790 )
Traditional herbal medicinal product used
as a mouthwash and gargles for relief of
minor inflammation of mucous
membranes of the oral cavity
Warning S
required
Oromucosal
K12-MI-RE-00-THM
EMA
Traditional herbal medicinal product used as a
mouthwash and gargles for relief of minor
inflammation of mucous membranes of the oral
cavity
Used in herbal medicine to help relieve
minor inflammations of mucous
membranes of the mouth (aphthous
stomatitis/canker sore) (demulcent)
Warning S
required
Buccal
K12-MI-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve minor
inflammations of mucous membranes of the mouth
(aphthous stomatitis/canker sore) (demulcent)
Traditionally used in herbal medicine as
an astringent to help relieve mild
inflammations of the mucous membranes
of the mouth
Warning S
required
Buccal
K12-MI-RE-HE-THM
HC
Traditionally used in Herbal Medicine as an
astringent to help relieve mild inflammations of the
mucous membranes of the mouth
Traditional herbal medicinal product for
management of minor ulcers and
inflammation in the mouth
Warning S
required
Topical
K12-MI-MG-00-THM
EMA
Traditional herbal medicinal product for treatment
of minor ulcers and inflammation in the mouth
practitioner.
322
323
324
325
326
327
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Buccal
K12-IR-RE-HE-THM
Page 42 of 92
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No
Proposed permitted indication
328
329
330
331
332
333
334
335
336
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditional herbal medicinal product for
the relief of symptoms of minor
inflammations of the oral mucosa
Warning S
required
Oromucosal
/Topical
K12-MI-RE-SY-THM
EMA
Traditional herbal medicinal product for the
symptomatic treatment of minor inflammations of
the oral mucosa
Relieves the symptoms of aphthous ulcers.
Warning S
required
Buccal
K12-SY-RE-00-S00
DENT3
For the symptomatic relief of aphthous ulcers.
Assists in the management of angular
stomatitis/chelitis (cracks in the corners
of the mouth)
Warning S
required
Topical
K13-00-MG-AS-S00
SKIN20
Treatment of cracks in the corners of the mouth
(angular stomatitis).
Relief of mouth ulcders
Warning S
required
Topical
K13-UL-RE-00-S00
ULC1
Relief of mouth ulcers
Relieves the symptoms of gastrooesophageal reflux (heartburn)
Warning S
required
Oral
K21-SY-RE-00-S00
DIG9
Traditionally used in herbal medicine to
help relieve dyspepsia
Warning S
required
Oral
K30-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve dyspepsia (Bradley 1992, Felter and Lloyd
1983[1898], Wren 1907)
Assists in the management of non-specific
dyspepsia.
Warning S
required
Oral
K30-DY-MG-AS-S00
GAST8
May assist in the management of non-specific
dyspepsia.
Relieves dyspepsia/indigestion
Warning S
required
Oral
K30-DY-RE-00-S00
GAST3
For the symptomatic relief of non-specific
dyspepsia.
Traditionally used in Herbal Medicien to
help relieve flatulent dyspepsia
Warning S
Oral
K30-FL-RE-HE-THM
HC
Traditionally used in Herbal Medicien to help
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Treatment of mild digestive disorders.
Page 43 of 92
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Ref
No
337
338
339
340
341
342
343
Proposed permitted indication
Label
disclaimers
(carminative)
required
Assists in the management of indigestion
Warning S
required
Oral
K30-IN-MG-AS-S00
DIG10
Relief of indigestion
Warning S
required
Oral
K30-IN-RE-00-S00
INDIG1/3
Relief of indigestion
Traditional herbal medicinal product for
the management of symptoms of mild
dyspeptic complaints such as heartburn
and bloating
Warning S
required
Oral
K30-MI-RE-SY-THM
EMA
Traditional herbal medicinal product for
symptomatic treatment of mild dyspeptic
complaints such as heartburn and bloating
Traditional herbal medicinal product used
in mild dyspeptic/gastrointestinal
disorders
Warning S
required
Oral
K30-MI-US-00-THM
EMA
Traditional herbal medicinal product used in mild
dyspeptic/gastrointestinal disorders
Traditionally used in herbal medicine to
help relieve nervous dyspepsia
Warning S
required
Oral
K30-NE-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve nervous dyspepsia/to help digestion in
cases of nervousness and/or stress
Relieves the symptoms of indigestion
Warning S
required
Oral
K30-SY-RE-00-S00
DIG5
Relief or treatment of
indigestion/heartburn/reflux
Traditional herbal medicinal product used
to increase bile flow for the relief of
symptoms of indigestion (such as
sensation of fullness, flatulence, and slow
digestion)
Warning S
required
EMA
Traditional herbal medicinal product used to
increase bile flow for the relief of symptoms of
indigestion (such as sensation of fullness,
flatulence, and slow digestion)
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
relieve flatulent dyspepsia (carminative)
Oral
K30-SY-RE-00-THM
Assists in the treatment of indigestion.
Page 44 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
344
Assists in the management of medically
diagnosed irritable bowel syndrome
Warning S2
required
Oral
K58-00-MG-AS-S00
345
Relieves the symptoms of medically
diagnosed irritable bowel syndrome
Warning S2
required
Oral
K58-SY-RE-00-S00
Assists in the management of constipation
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Oral
Assists in the prevention of constipation.
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Assists in the relief of constipation.
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
346
347
348
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Source
Source indication
GAST10
May assist in the management of medically
diagnosed irritable bowel syndrome
GAST5
For the symptomatic relief of medically diagnosed
irritable bowel syndrome
K59-00-MG-AS-S00
GAST12
May assist in the management of constipation
Oral
K59-00-PV-AI-S00
LAX1/3
Laxative. Aids or assists in the prevention of
constipation./ Promotes elimination and rids the
body of waste.
Oral
K59-00-RE-AS-S00
CONST1
Aids or assists in the relief of constipation.
Page 45 of 92
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Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Used in herbal medicine to provide gentle
relief of constipation and/or irregularity
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Oral
K59-00-RE-GE-NHM
HC
Used in Herbal Medicine to provide gentle relief of
constipation and/or irregularity
Herbal medicinal product for the
management of habitual constipation
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Oral
K59-HA-MG-00-NHM
EMA
Herbal medicinal product for the treatment of
habitual constipation
Gentle relief of occasional constipation
(irregularity)
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Oral
K59-OC-RE-GE-S00
HC
Gentle relief of occasional constipation
(irregularity)
Used in herbal medicine for the short-term
relief of occasional constipation
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Oral
K59-OC-RE-ST-NHM
HC
(Used in Herbal Medicine for the) short-term relief
of occasional constipation
349
350
351
352
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 46 of 92
Therapeutic Goods Administration
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Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used in herbal medicine for
short-term use in cases of occasional
constipation
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Oral
K59-OC-US-ST-THM
EMA
Traditional herbal medicinal product for shortterm use in cases of occasional constipation
Relieves the symptoms of constipation
Warnings S
and LAX1
required /
LAX2 & LAX 3
required in
certain
circumstances
Oral
K59-SY-RE-00-S00
GAST7
For the symptomatic relief of constipation
355
Relieves the symptoms of mild digestive
disorders.
Warning S
required
Oral
K92-SY-RE-00-S00
GAST1
Relief of the symptoms/pain/discomfort of
gastritis.
356
Relief of the pain of mild digestive
disorders.
Warning S
required
Oral
K92-PA-RE-00-S00
GAST1
Relief of the symptoms/pain/discomfort of
gastritis.
357
Relief of the discomfort of mild digestive
disorders.
Warning S
required
Oral
K92-DI-RE-00-S00
GAST1
Relief of the symptoms/pain/discomfort of
gastritis.
358
Traditionally used in herbal medicine to
stimulate the appetite (orexigenic)
Oral
KAP-00-ST-00-THM
HC
Traditionally used in Herbal Medicine to stimulate
the appetite (orexigenic)
Traditionally used in herbal medicine to
Oral
KAP-00-ST-HE-THM
HC
Traditionally used in Herbal Medicine to help
stimulate appetite (ESCOP 2003, Bradley 1992,
353
354
359
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 47 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
help stimulate appetite
Grieve 1971[1931])
Traditionally used in herbal medicine as
an aromatic bitter to increase appetite
(stomachic)
Oral
KAP-AB-IN-BI-THM
HC
Traditionally used in Herbal Medicine as an
aromatic bitter to aid digestion and to increase
appetite (stomachic) (Mills and Bone 2005 ,
Bradley 1992 , Grieve 1971[1931] )
Traditionally used in herbal medicine as a
bitter to increase appetite
Oral
KAP-BI-IN-BI-THM
HC
Traditionally used in Herbal Medicine as a bitter to
increase appetite
Used in herbal medicine to increase bile
excretion by the liver (choleretic)
Oral
KBI-EX-IN-00-NHM
HC
Used in Herbal Medicine to increase bile excretion
by the liver (choleretic) and stimulate contraction
of the gallbladder (cholagogue)
363
Used in herbal medicine to help increase
bile flow (cholagogue)
Oral
KBI-FL-IN-HE-NHM
HC
Used in Herbal Medicine to help increase bile flow
(cholagogue)
364
Traditionally used in herbal medicine to
help increase bile flow (cholagogue)
Oral
KBI-FL-IN-HE-THM
HC
Traditionally used in Herbal Medicine to help
increase bile flow (cholagogue)
365
Traditionally used in herbal medicine to
stimulate secretion of bile (choleretic)
Oral
KBI-SE-ST-00-THM
HC
Traditionally used in Herbal Medicine to stimulate
secretion of bile (choleretic)
366
Used in herbal medicine to promote bowel
movements by increasing bulk volume and
water content
LAX1, LAX2 &
LAX3
Oral
KBO-MO-PR-BW-NHM
HC
Used in Herbal Medicine to promote bowel
movements by increasing bulk volume and water
content
Used in herbal medicine to promote bowel
movement (by direct action on the large
LAX1, LAX2 &
LAX3
Oral
KBO-MO-PR-DA-NHM
HC
Used in Herbal Medicine to promote bowel
movement (by direct action on the large intestine)
360
361
362
367
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 48 of 92
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No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
intestine)
368
To promote bowel movement (by direct
action on the large intestine)
LAX1, LAX2 &
LAX3
Oral
KBO-MO-PR-DA-S00
HC
To promote bowel movement (by direct action on
the large intestine)
369
Traditionally used in herbal medicine to
manage digestive disturbances
(dyspepsia)
Warning S
required
Oral
KDD-00-MG-00-THM
HC
Traditionally used in Herbal Medicine to treat
digestive disturbances (dyspepsia)
Traditionally used in herbal medicine to
help relieve digestive disturbances
including bloating and flatulence
Warning S
required
Oral
KDD-BF-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve digestive disturbances including bloating
and flatulence
Traditional herbal medicinal product for
symptomatic relief of digestive disorders
such as dyspepsia and flatulence
Warning S
required
Oral
KDD-DF-RE-SY-THM
EMA
Traditional herbal medicinal product for
symptomatic relief of digestive disorders such as
dyspepsia and flatulence
Traditional herbal medicinal product for
the releif of symptoms of digestive
disorders such as dyspepsia with a
sensation of fullness, bloating and
flatulence
Warning S
required
Oral
KDD-DY-RE-00-THM
EMA
Traditional herbal medicinal product for the
symptomatic relief of digestive disorders such as
dyspepsia with a sensation of fullness, bloating and
flatulence
Used in herbal medicine to help relieve
digestive disturbances, such as dyspepsia
Warning S
required
Oral
KDD-DY-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve digestive
disturbances, such as dyspepsia (Bradley 2006 ,
ESCOP 2003 , Blumenthal et al. 2000 )
Traditionally used in herbal medicine to
help relieve digestive disturbances, such
Warning S
required
Oral
KDD-DY-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve digestive disturbances, such as dyspepsia
370
371
372
373
374
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 49 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
HC
Traditionally used in Herbal Medicine to help
relieve digestive disturbances such as flatulent
dyspepsia (carminative) (Bradley 2006 , ESCOP
2003 , Hoffmann 2003 , Blumenthal et al. 2000 ,
Felter and Lloyd 1983[1898] )
as dyspepsia
375
Traditionally used in herbal medicine to
help relieve digestive disturbances such as
flatulent dyspepsia (carminative)
376
Warning S
required
Oral
KDD-FD-RE-HE-THM
Traditionally used in herbal medicine to
help relieve digestive upset/disturbances
including lack of appetite, nausea,
digestive spasms, indigestion, dyspepsia,
and flatulent colic (carminative)
Warning S
required
Oral
KDD-LA-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve digestive upset/disturbances including lack
of appetite, nausea, digestive spasms, indigestion,
dyspepsia and flatulent colic (carminative) (Mills
and Bone 2000 , Bradley 1992 , Ellingwood
1983[1919] , Felter and Lloyd 1983[1898] )
Traditionally used in herbal medicine to
help relieve mild digestive disturbances
such as dyspepsia, flatulence, bloating, and
belching
Warning S
required
Oral
KDD-MI-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve mild digestive disturbances such as
dyspepsia, flatulence, bloating, and belching
378
Used for the management of mild
digestive disorders,
Warning S
required
Oral
KDD-MI-MG-00-S00
DIG9
Treatment of mild digestive disorders,
379
Traditional herbal medicinal product for
the management of symptoms of mild,
spasmodic gastrointestinal complaints
including bloating and flatulence
Warning S
required
Oral
KDD-MI-MG-SY-THM
EMA
Traditional herbal medicinal product for
symptomatic treatment of mild, spasmodic
gastrointestinal complaints including bloating and
flatulence
Traditional herbal medicinal product for
the relief of symptoms related to mild
digestive disorders (such as feeling of
Warning S
required
Oral
KDD-SY-RE-00-THM
EMA
Traditional herbal medicinal product for the relief
of symptoms related to mild digestive disorders
(such as feeling of abdominal fullness, flatulence
377
380
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 50 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
abdominal fullness, flatulence and slow
digestion)
Source indication
and slow digestion) and temporary loss of appetite
381
Used in herbal medicine to aid digestion
Oral
KDI-00-AI-00-NHM
HC
Used in Herbal Medicine to aid digestion (ESCOP
2003 , Williamson 2003 , Blumenthal et al. 2000 ,
Mills and Bone 2000 )
382
Aids digestive function/digestion
Oral
KDI-00-AI-00-S00
DIG1
Aids digestion
383
Traditionally used in herbal medicine to
aid digestion (stomachic)
Oral
KDI-00-AI-00-THM
HC
Traditionally used in Herbal Medicine to aid
digestion (stomachic)
384
385
Traditionally used in herbal medicine as a
bitter to aid digestion
Oral
KDI-00-AI-BI-THM
HC
Traditionally used in Herbal Medicine as a bitter to
aid digestion (Mills and Bone 2005 , Boon and
Smith 2004 , Hoffmann 2003 , Ellingwood
1983[1919] , Wren 1907 )
Traditionally used in herbal medicine to
stimulate digestion
Oral
KDI-00-ST-00-THM
HC
Traditionally used in Herbal Medicine to stimulate
digestion (Bradley 2006, Felter and Lloyd
1983[1898])
386
Oral
KDI-FA-DA-AS-S00
DIG7/8
Aids digestion and may be used to assist in the
distribution and assimilation of fats in the digestive
system/ Aids digestion and contains lipotropic
factors to assist with distribution and assimilation
of fats in the digestive system.
Oral
KDI-HE-MA-HE-S00
DIG2
Helps maintain healthy digestive function
Used to assist in the distribution and
assimilation of fats in the digestive system.
387
Helps maintain healthy digestive function
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 51 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
388
389
390
391
392
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Digestive enzyme to assist in the digestion
of foods containing lactose (e.g. dairy
foods, milk).
Oral
KDI-LA-AS-00-S00
HC
Digestive enzyme/lactase to assist in the digestion
of foods containing lactose (e.g. dairy foods, milk).
Aids digestion.
Oral
KDI-LT-AI-00-S00
DIG3
Liver tonic. Aids digestion.
Helps maintain healthy digestive function.
Oral
KDI-LT-MA-HE-S00
DIG4
Liver tonic. Helps maintain healthy digestive
function.
For the management of indigestion.
Warning S
required
Oral
KDI-LT-MG-00-S00
INDIG4
Liver tonic. Treatment of indigestion.
Traditionally used in herbal medicine to
aid digestion in cases of nervousness
and/or stress
Warning S
required
Oral
KDI-NS-AI-00-THM
HC
Traditionally used in Herbal Medicine to help
relieve nervous dyspepsia/to help digestion in
cases of nervousness and/or stress
393
Traditionally used in herbal medicine as a
digestive tonic to aid digestion
Oral
KDI-TO-AI-00-THM
HC
(Traditionally) used in Herbal Medicine as a
digestive tonic to aid digestion
394
Traditionally used as a digestive stimulant
(an aromatic)
Oral
KDS-AR-US-00-T00
HC
Traditionally used as a digestive stimulant (an
aromatic) (Hoffman 1996; Felter and Lloyd 1983).
395
Used in herbal medicine to stimulate
contraction of the gallbladder
(cholagogue)
Oral
KGA-CT-ST-00-NHM
HC
Used in Herbal Medicine to increase bile excretion
by the liver (choleretic) and stimulate contraction
of the gallbladder (cholagogue)
Oral
KGC-00-RE-00-S00
BM12
Alleviate/relieve gastrointestinal upsets such as
dyspepsia and loss of appetite
396
Relieves gastrointestinal discomfort
Warning S
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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No
Proposed permitted indication
397
398
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditional herbal medicinal product for
use as a demulcent preparation for the
relief of symptoms of mild gastrointestinal
discomfort
Warning S
required
Oral
KGC-00-RE-SY-THM
EMA
Traditional herbal medicinal product for use as a
demulcent preparation for the symptomatic relief
of mild gastrointestinal discomfort
Traditional herbal medicinal product for
the relief of symptoms of mild, spasmodic
gastrointestinal complaints including
bloating and flatulence
Warning S
required
EMA
Traditional herbal medicinal product for the
symptomatic treatment of mild, spasmodic
gastrointestinal complaints including bloating and
flatulence
Oral
KGC-MI-RE-SY-THM
399
Provides live microorganisms that
contribute to a natural healthy gut flora
Oral
KGF-HE-CO-LM-S00
HC
Provides live microorganisms that contribute to a
natural healthy gut flora (Tappenden and Deutsch
2007; Reid et al. 2003; Isolauri 2001; Lu and
Walker 2001; Saavedra 2001).
400
Probiotic that contributes to a natural
healthy gut flora
Oral
KGF-HE-CO-PB-S00
HC
Probiotic that contributes to a natural healthy gut
flora
401
Probiotic that forms part of a natural
healthy gut flora
Oral
KGF-HE-FO-PB-S00
HC
Probiotic that forms part of a natural healthy gut
flora
Helps in the maintenance of healthy gums
Oral
KGU-00-DM-HE-S00
HC
Helps in the development and maintenance of
gums
Helps in the development of healthy gums
Oral
KGU-00-DE-HE-S00
HC
Helps in the development and maintenance of
gums
Buccal
KGU-SO-MG-AS-S00
DENT4
May assist in the management of sore gums
402
403
404
Assists in the management of sore gums
Warning S
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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No
405
406
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Warning S
required
Buccal
KGU-SO-RE-00-S00
DENT1
For the symptomatic relief of sore gums
Oral
KHE-PS-SU-HE-S00
HC
Helps support digestive system health after periods
of physical stress
Used as a laxative
Warning S,
LAX1 & LAX2
& LAX3
required
Oral
KLA-00-US-00-S00
LAX2
Laxative. Aids or assists in the treatment of
constipation.
Used in herbal medicine as a bulk-forming
laxative
Warnings
LAX1 required
/ LAX2 & LAX
3 required in
certain
circumstances
Oral
KLA-BF-US-00-NHM
HC
Used in Herbal Medicine as a bulk-forming laxative
Used in herbal medicine as a mild laxative
Warnings
LAX1 required
/ LAX2 & LAX
3 required in
certain
circumstances
Oral
KLA-MI-US-00-NHM
HC
Used in Herbal Medicine as a mild laxative
Traditionally used in herbal medicine as a
mild laxative
Warnings
LAX1 required
/ LAX2 & LAX
3 required in
certain
Oral
KLA-MI-US-00-THM
HC
Traditionally used as a mild laxative (Hoffmann
2003, Williamson et al. 1988, Mills 1985)
Relief of the discomfort of sore gums
Helps support digestive system health
after periods of physical stress
407
408
409
410
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Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Oral
KLA-ST-US-00-THM
HC
Traditionally used in Herbal Medicine as a
stimulant laxative
circumstances
411
Traditionally used in herbal medicine as a
stimulant laxative
Warnings
LAX1 required
/ LAX2 & LAX
3 required in
certain
circumstances
412
Used in herbal medicine to help support
liver function
Oral
KLI-FU-SU-HE-NHM
HC
Used in Herbal Medicine to help support liver
function
413
Helps to support liver function in healthy
people
Oral
KLI-FU-SU-HE-S00
Liver 2/3,
HC
Helps to support liver function
414
Traditionally used in herbal medicine as a
hepatoprotectant/liver protectant
Oral
KLP-00-US-00-THM
HC
Traditionally used in Herbal Medicine as a
hepatoprotectant/ liver protectant
415
Maintenance of healthy mucous
membranes
Oral
KMM-HE-MA-AS-S00
BM02
Maintenance of healthy mucous membranes
416
Helps to support mucous membrane
health
Oral
KMM-HE-SU-HE-S00
HC
Helps to maintain membranes
Oral
KRE-00-MA-HE-S00
LAX5
A bulk producing laxative (fibre supplement) for
the maintenance of regularity
417
Helps maintain regularity (bowel)
Warnings
LAX1 required
/ LAX2 & LAX
3 required in
certain
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 55 of 92
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No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
HC
Traditionally used in Herbal Medicine to help
relieve digestive spasms (anti-spasmodic) (Bradley
2006, Williamson et al. 1988, Felter and Lloyd
1983[1898], Grieve 1971[1931])
EMA
Herbal medicinal product for the symptomatic
relief of minor spasms of the gastrointestinal tract,
flatulence and abodominal pain, especially in
patients with irritable bowel syndrome
circumstances
418
419
Traditionally used in herbal medicine to
help relieve digestive spasms (antispasmodic)
Herbal medicinal product for the relief of
symptoms of minor spasms of the
gastrointestinal tract, flatulence and
abodominal pain, especially in patients
with medically diagnosed irritable bowel
syndrome
Warning S
required
Oral
KSP-00-RE-HE-THM
Warning S2
required
Oral
KSP-MI-RE-SY-SHM
420
Helps in the development and
maintenance of teeth
Oral
KTE-00-DM-HE-S00
HC
Helps in the development and maintenance of
teeth/Source of vitamin A to help in the
development and maintenance of teeth/Provitamin
A to help in the development and maintenance of
teeth
Traditionally used in herbal medicine as a
digestive tonic and bitter to help stimulate
appetite and aid digestion (stomachic)
Oral
KTO-BI-US-00-THM
HC
Traditionally used in Herbal Medicine as a
digestive tonic and bitter to help stimulate appetite
and aid digestion (stomachic)
422
Liver tonic.
Oral
KTO-LT-US-00-S00
LIVER1
Liver tonic.
423
Traditionally used in herbal medicine as a
digestive tonic/digestive aid (stimulant)
Oral
KTO-ST-US-00-THM
HC
Traditionally used in Herbal Medicine as a
digestive tonic/digestive aid (stimulant)
421
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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Proposed permitted indication
424
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used in Traditional Chinese
Medicine (TCM) to support the healing of
carbuncles
Warning S
required
Topical
L02-00-HE-PR-TCM
HC
Traditionally used in TCM to promote healing of
carbuncles (Bensky and Gamble 1993, Li 1973)
Assists in the management of boils
Warning S
required
Topical
L02-00-MG-AS-S00
BOIL2
May assist in the management of boils
Traditional herbal medicinal product for
the management of minor wounds and
small boils (furuncles)
Warning S
required
Topical
L02-MI-MG-00-THM
EMA
Traditional herbal medicinal product for treatment
of minor wounds and small boils (furuncles)
Relieves the symptoms of boils
Warning S
required
Topical
L02-SY-RE-00-S00
BOIL1
For the symptomatic relief of boils
428
Assists in the management of medically
diagnosed dermatitis
Warning S2
required
Topical
L20-00-MG-AS-S00
SKIN11
May assist in the management of dermatitis
429
Relieves the symptoms of medically
diagnosed dermatitis
Warning S2
required
Topical
L20-00-RE-SY-S00
SKIN3
For the symptomatic relief of dermatitis.
430
For the management of medically
diagnosed eczema or dermatitis.
Warning S2
required
Oral or
topical
SKIN19
L20-00-MG-00-S00
Treatment of minor skin disorders such as wounds,
scratches, eczema, dermatitis, bruising, cuts and
abrasions.
Traditional herbal medicinal product used
in management of seborrhoeic skin
conditions
Warning S
required
Topical
L21-00-MG-00-THM
425
426
427
431
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
EMA
Traditional herbal medicinal product used in
treatment of seborrhoeic skin conditions
Page 57 of 92
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No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
432
Traditional herbal medicinal product used
in seborrheoic skin conditions
Warning S
required
Topical
L21-00-US-00-THM
EMA
Traditional herbal medicinal product used in
seborrhoeic skin conditions
Reduces the recurrence of symptoms
associated with dandruff
Warning S
required
HC
For the relief of (controls, helps prevent, and/or
reduces the recurrence of) dandruff and/or the
symptoms (itching, irritation, redness, flaking
and/or scaling) associated with dandruff
Relieves symptoms associated with
dandruff
Warning S
required
Topical
L21-SY-RE-00-S00
HC
For the relief of (controls, helps prevent, and/or
reduces the recurrence of) dandruff and/or the
symptoms (itching, irritation, redness, flaking
and/or scaling) associated with dandruff
Assists in the management of itchy ears
Warning S
required
Topical
L29-EA-MG-AS-S00
EAR5
May assist in the management of itchy ears
Relieves itchy ears
Warning S
required
Topical
L29-EA-RE-00-S00
EAR2
For the symptomatic relief of itchy ears
437
Relieves the symptoms of medically
diagnosed eczema.
Warning S2
required
Oral or
topical
L30-SY-RE-00-S00
ECZ
Relief of the symptoms of eczema.
438
Relieves the skin symptoms of medically
diagnosed psoriasis
Warning S2
required
Topical
L40-SY-RE-00-SSK
PSOR1
Relief of the effects of psoriasis on the skin.
439
For the management of the skin symptoms
of medically diagnosed psoriasis
Warning S2
required
Topical
L40-SY-MG-00-SSK
PSOR2
Treatment of the effects of psoriasis on the skin.
433
Topical
L21-SY-RD-00-S00
434
435
436
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
440
Assists in the management of medically
diagnosed psoriasis.
Warning S2
required
Oral
L40-00-MG-AS-S00
Assists in the management of urticaria
Warning S
required
Topical
Relieves the symptoms of urticaria
Warning S
required
443
Assists in the management of minor
[burns / sunburn]
444
445
Source
Source indication
SKIN10
May assist in the management of psoriasis.
L50-00-MG-AS-S00
SKIN16
May assist in the management or urticaria.
Topical
L50-SY-RE-00-S00
SKIN8
For the symptomatic relief of urticaria.
Warning S
required
Topical
L55-MI-MG-AS-S00
SKIN14
May assist in the management of minor burns
(including sunburn).
Relieves the symptoms of minor burns
(including sunburn).
Warning S
required
Topical
L55-SY-RE-00-S00
SKIN6
For the symptomatic relief of minor burns
(including sunburn).
Assist in the management of alopecia.
Warning S
required
Oral or
topical
L63-00-MG-AS-S00
HAIR
May assist in the management of alopecia.
Assists in the management of acne
Warning S
required
Topical
L70-00-MG-AS-S00
SKIN17
Treatment of acne
447
Helps prevent new acne pimples from
forming
Warning S
required
Topical
L70-00-PV-HE-S00
HC
Helps prevent new acne pimples from forming
448
Assists in the management of
mild/moderate acne
Warning S
required
Topical
L70-MI-MG-AS-S00
SKIN13
May assist in the management of mild to moderate
acne
441
442
446
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 59 of 92
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449
450
451
452
453
454
455
456
457
Proposed permitted indication
Relief of mild to moderate acne
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Warning S
required
Topical
L70-MI-RE-00-S00
SKIN5
For the symptomatic relief of mild to moderate
acne.
Assists in the prevention of bed sores. (or)
Assists in the prevention of decubitus
ulcers.
ULC2
L89-00-PV-AS-S00
Assists in the prevention of bed sores. (or) Assists
in the prevention of decubitus ulcers.
Traditionally used in herbal medicine to
relieve symptoms of chronic cutaneous
diseases
Warning S
required
Oral
LCD-SC-RE-00-THM
HC
Traditionally used in Herbal Medicine to relieve
symptoms of chronic cutaneous diseases
Traditional herbal medicinal product for
symptomatic management of cutaneous
capillary fragility
Warning S
required
Oral
LCF-SY-MG-00-THM
EMA
Traditional herbal medicinal product for
symptomatic treatment of cutaneous capillary
fragility
Oral
LCO-00-FO-HE-S00
HC
Helps in collagen formation
LDA-00-MG-00-S00
DAN1
Treatment of dandruff.
Helps in collagen formation to support
skin and connective tissue health
Manages dandruff
Warning S
required
Relieves dry skin
Warning S
required
Topical
LDS-00-RE-SY-S00
SKIN4
For the symptomatic relief of dry skin.
Assists in the management of dry skin
Warning S
required
Topical
LDS-MA-AS-00-S00
SKIN12
May assist in the management of dry skin.
Traditional herbal medicinal product for
relief of minor skin inflammation and
Warning S
Topical
LID-MI-RE-00-THM
EMA
Traditional herbal medicinal product for relief of
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 60 of 92
Therapeutic Goods Administration
Proposed permitted indication
Label
disclaimers
dryness of the skin
required
minor skin inflammation and dryness of the skin
Traditionally used in herbal medicine to
help relieve minor skin inflammations and
irritations
Warning S
required
Topical
LII-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve skin inflammations and irritations (Bradley
2006, ESCOP 2003, Hoffmann 2003, Blumenthal et
al. 2000, Felter and Lloyd 1983[1898])
Traditionally used in herbal medicine to
help heal minor skin wounds, burns,
irritations and local inflammations
Warning S
required
Topical
LII-MI-HE-HE-THM
HC
Traditionally used in Herbal Medicine to help heal
minor skin wounds, burns, irritations and local
inflammations
Used in herbal medicine to help relieve
minor inflammation and/or irritation of
the skin
Warning S
required
Topical
LII-MI-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve minor
inflammation and/or irritation of the skin
461
Traditional herbal medicinal product for
relief of minor skin inflammations
Warning S
required
Topical
LIN-MI-RE-00-THM
EMA
Traditional herbal medicinal product for relief of
minor skin inflammations
462
Traditional herbal medicinal product for
the symptomatic management of minor
inflammations of the skin
Warning S
required
Topical
LIN-MI-MG-SY-THM
EMA
Traditional herbal medicinal product for the
symptomatic treatment of minor inflammations of
the skin
Helps maintain healthy nails
Warning S
required
Oral
LNA-HE-MA-HE-S00
BM21
Helps increase nail thickness, strengthen brittle
nails and reduce nail brittleness, splitting and
chipping
Relieves the symptoms of localised
pruritic conditions in intact skin
Warning S
required
Topical
LPR-LO-RE-SY-S00
EMA
For the symptomatic relief of localised pruritic
conditions in intact skin
Ref
No
458
459
460
463
464
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Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
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Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
SUNSC5
A broad spectrum sunscreening preparation of
SPF4 or greater. Can aid in the prevention of
premature skin ageing.
465
Aids in the prevention of premature skin
ageing
466
Assists in management of dry or inflamed
skin conditions.
467
LSA-PR-PR-AI-S00
Topical
Warning S
required
Topical
LSK-DI-MG-00-S00
SKIN18
Treatment of dry or inflamed skin conditions.
Helps to maintain healthy skin
Oral
LSK-HE-MA-HE-S00
HC
Helps to maintain healthy skin
Supports skin health
Oral
LSK-HE-SU-00-S00
SAN15/FN
FC
Beneficial for healthy skin/helps to maintain skin
and mucosa healthy
469
Broad Spectrum Sunscreen
Topical
LSK-00-SS-BS-S00
BROADS
Broad Spectrum Sunscreen
470
Sunscreen SPF4
Topical
LSK-04-SS-00-S00
SPF04
Sunscreen SPF4
471
Sunscreen SPF6
Topical
LSK-06-SS-00-S00
SPF06
Sunscreen SPF6
472
Sunscreen SPF8
Topical
LSK-08-SS-00-S00
SPF08
Sunscreen SPF8
473
Sunscreen SPF10
Topical
LSK-10-SS-00-S00
SPF10
Sunscreen SPF10
474
Sunscreen SPF12
Topical
LSK-12-SS-00-S00
SPF12
Sunscreen SPF12
475
Sunscreen SPF15
Topical
LSK-15-SS-00-S00
SPF15
Sunscreen SPF15
468
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Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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Proposed permitted indication
476
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Sunscreen SPF16
Topical
LSK-16-SS-00-S00
SPF16
Sunscreen SPF16
477
Sunscreen SPF17
Topical
LSK-17-SS-00-S00
SPF17
Sunscreen SPF17
478
Sunscreen SPF18
Topical
LSK-18-SS-00-S00
SPF18
Sunscreen SPF18
479
Sunscreen SPF19
Topical
LSK-19-SS-00-S00
SPF19
Sunscreen SPF19
480
Sunscreen SPF20
Topical
LSK-20-SS-00-S00
SPF20
Sunscreen SPF20
481
Sunscreen SPF21
Topical
LSK-21-SS-00-S00
SPF21
Sunscreen SPF21
482
Sunscreen SPF22
Topical
LSK-22-SS-00-S00
SPF22
Sunscreen SPF22
483
Sunscreen SPF23
Topical
LSK-23-SS-00-S00
SPF23
Sunscreen SPF23
484
Sunscreen SPF24
Topical
LSK-24-SS-00-S00
SPF24
Sunscreen SPF24
485
Sunscreen SPF25
Topical
LSK-25-SS-00-S00
SPF25
Sunscreen SPF25
486
Sunscreen SPF26
Topical
LSK-26-SS-00-S00
SPF26
Sunscreen SPF26
487
Sunscreen SPF27
Topical
LSK-27-SS-00-S00
SPF27
Sunscreen SPF27
488
Sunscreen SPF28
Topical
LSK-28-SS-00-S00
SPF28
Sunscreen SPF28
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Permitted (coded) indications for listed medicines - Consultation paper
January 2013
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Proposed permitted indication
489
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Sunscreen SPF29
Topical
LSK-29-SS-00-S00
SPF29
Sunscreen SPF29
490
Sunscreen SPF30
Topical
LSK-30-SS-00-S00
SPF30
Sunscreen SPF30
491
Sunscreen SPF40
Topical
LSK-40-SS-00-S00
SPF30
Sunscreen SPF30
492
Sunscreen SPF50
Topical
LSK-50-SS-00-S00
SPF30
Sunscreen SPF30
493
Sunscreen SPF50 Plus
Topical
LSK-S+-SS-00-S00
SPF30
Sunscreen SPF30
494
A broad spectrum sunscreening
preparation of SPF30+. Can aid in the
prevention of sunspots.
LSK-30+-S1-BS-S00
Topical
SUNSC1/2
/3/4
A broad spectrum sunscreening preparation of
SPF30+. May assist in preventing some skin
cancers
A broad spectrum sunscreening
preparation of SPF30+. Assists in
preventing some skin cancers.
LSK-30+-S2-BS-S00
Topical
SUNSC1/2
/3/4
A broad spectrum sunscreening preparation of
SPF30+. May reduce the risk of some skin cancers
LSK-30+-S3-BS-S00
SUNSC1/2
/3/4
A broad spectrum sunscreening preparation of
SPF30+. Can aid in the prevention of solar
keratoses
LSK-30+-S4-BS-S00
SUNSC1/2
/3/4
A broad spectrum sunscreening preparation of
SPF30+. Can aid in the prevention of sunspots.
LSK-04-SS-BS-S00
SUNSC5
A broad spectrum sunscreening preparation of
SPF4 or greater. Can aid in the prevention of
495
496
497
Label
disclaimers
A broad spectrum sunscreening
preparation of SPF30+. Helps reduce the
risk of some skin cancers.
Topical
A broad spectrum sunscreening
preparation of SPF30+. Aids in the
prevention of solar keratoses
Topical
498
A broad spectrum sunscreening
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Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Topical
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Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
preparation of SPF4 or greater.
499
500
501
502
503
504
505
A broad spectrum sunscreening
preparation of SPF50+. Can aid in the
prevention of sunspots.
premature skin ageing.
LSK-50+-S1-BS-S00
Topical
A broad spectrum sunscreening
preparation of SPF50+. Assists in
preventing some skin cancers.
Topical
A broad spectrum sunscreening
preparation of SPF50+. Helps reduce the
risk of some skin cancers.
Topical
SUNSC9
A broad spectrum sunscreening preparation of
SPF30+. Can aid in the prevention of sunspots.
SUNSC6
A broad spectrum sunscreening preparation of
SPF50+. May assist in preventing some skin
cancers .
SUNSC7
A broad spectrum sunscreening preparation of
SPF50+. May reduce the risk of some skin cancers.
SUNSC8
A broad spectrum sunscreening preparation of
SPF50+. Can aid in the prevention of solar
keratoses
SUNSC9
A broad spectrum sunscreening preparation of
SPF30+. Can aid in the prevention of sunspots.
SUNSC14
A broad spectrum sunscreening preparation of
SPF30. May assist in preventing some skin cancers .
SUNSC15
A broad spectrum sunscreening preparation of
SPF30. May reduce the risk of some skin cancers.
LSK-50+-S2-BS-S00
LSK-50+-S3-BS-S00
A broad spectrum sunscreening
preparation of SPF50+. Aids in the
prevention of solar keratoses
Topical
A broad spectrum sunscreening
preparation of SPF30. Can aid in the
prevention of sunspots.
Topical
A broad spectrum sunscreening
preparation of SPF30. Assists in
preventing some skin cancers.
Topical
A broad spectrum sunscreening
preparation of SPF30. Helps reduce the
risk of some skin cancers.
Topical
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Source indication
LSK-50+-S4-BS-S00
LSK-30-S1-BS-S00
LSK-30-S2-BS-S00
LSK-30-S3-BS-S00
Page 65 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
506
A broad spectrum sunscreening
preparation of SPF30. Aids in the
prevention of solar keratoses
Topical
A broad spectrum sunscreening
preparation of SPF40. Can aid in the
prevention of sunspots.
Topical
A broad spectrum sunscreening
preparation of SPF40. May assist in
preventing some skin cancers.
Topical
A broad spectrum sunscreening
preparation of SPF40. Helps reduce the
risk of some skin cancers.
Topical
A broad spectrum sunscreening
preparation of SPF40. Aids in the
prevention of solar keratoses
Topical
A broad spectrum sunscreening
preparation of SPF50. Can aid in the
prevention of sunspots.
Topical
A broad spectrum sunscreening
preparation of SPF50. Assists in
preventing some skin cancers.
Topical
507
508
509
510
511
512
513
Label
disclaimers
A broad spectrum sunscreening
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
SUNSC16
A broad spectrum sunscreening preparation of
SPF30. Can aid in the prevention of solar keratoses
SUNSC9
A broad spectrum sunscreening preparation of
SPF30+. Can aid in the prevention of sunspots.
SUNSC18
A broad spectrum sunscreening preparation of
SPF40. May assist in preventing some skin cancers .
SUNSC19
A broad spectrum sunscreening preparation of
SPF40. May reduce the risk of some skin cancers.
SUNSC20
A broad spectrum sunscreening preparation of
SPF40. Can aid in the prevention of solar keratoses
SUNSC9
A broad spectrum sunscreening preparation of
SPF30+. Can aid in the prevention of sunspots.
SUNSC10
A broad spectrum sunscreening preparation of
SPF50. May assist in preventing some skin cancers .
LSK-30-S4-BS-S00
LSK-40-S1-BS-S00
LSK-40-S2-BS-S00
LSK-40-S3-BS-S00
LSK-40-S4-BS-S00
LSK-50-S1-BS-S00
LSK-50-S2-BS-S00
Topical
LSK-50-S3-BS-S00
SUNSC11
A broad spectrum sunscreening preparation of
Page 66 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
preparation of SPF50. Helps reduce the
risk of some skin cancers.
514
SPF50. May reduce the risk of some skin cancers.
A broad spectrum sunscreening
preparation of SPF50. Aids in the
prevention of solar keratoses
Topical
Helps maintain skin and membranes
Oral
Aids in the prevention of sunspots.
Topical
LSK-50-S4-BS-S00
SUNSC12
515
516
517
518
519
520
Source indication
Used in herbal medicine to aid in the
healing of minor wounds and cuts
(vulnerary)
Warning S
required
Traditionally used in Ayurveda to assist in
the healing of minor wounds such as cuts
and burns, and minor skin irritations
Warning S
required
Topical
Traditionally used in herbal medicine to
assist healing of minor wounds such as
cuts and burns, and minor skin irritations
Warning S
required
Traditionally used in herbal medicine to
aid in the healing of minor wounds and
Warning S
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
LSM-00-MA-HE-S00
LSS-00-PR-AI-S00
HC
SUNSC4
A broad spectrum sunscreening preparation of
SPF50. Can aid in the prevention of solar keratoses
Provitamin A to help maintain skin and
membranes/Source of vitamin A to help maintain
skin and membranes
A broad spectrum sunscreening preparation of
SPF30+. Can aid in the prevention of sunspots.
HC
Used in Herbal Medicine to aid in the healing of
minor wounds and cuts (vulnerary)
LWC-MI-HE-AS-TAY
HC
Traditionally used in Ayurveda to relieve pain and
inflammation, and assist in the healing of minor
wounds such as cuts and burns, and minor skin
irritations
Topical
LWC-MI-HE-AS-THM
HC
(Traditionally used in Herbal Medicine to) assist(s)
healing of minor wounds such as cuts and burns,
and minor skin irritations
Topical
LWH-MI-HE-AI-THM
HC
Traditionally used in Herbal Medicine to aid in the
healing of minor wounds and cuts (vulnerary)
Topical
LWC-MI-HE-AI-NHM
Page 67 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Warning S
required
Topical
LWO-SM-MG-00-THM
EMA
Traditional herbal medicinal product for the
treatment of small superficial wounds
HC
Traditionally used in Herbal Medicines as an
antiseptic and/or antimicrobial to help treat minor
wounds and sores (Bradley 2006 , McIntyre 2005 ,
Hoffmann 2003 , Blumenthal et al. 2000 , Bove
1996 )
HC
Traditionally used in Herbal Medicines as an
antiseptic and/or antimicrobial to help treat minor
wounds and sores (Bradley 2006 , McIntyre 2005 ,
Hoffmann 2003 , Blumenthal et al. 2000 , Bove
1996 )
GOUT1
Temporary relief of pain associated with gout.
cuts (vulnerary)
521
Traditional herbal medicinal product for
the management of small superficial
wounds
522
Traditionally used in herbal medicine as
an antimicrobial to help manage minor
wounds and sores
Warning S
required
Topical
LWS-MI-TR-AM-THM
523
Traditionally used in herbal medicine as
an antiseptic to help manage minor
wounds and sores
Warning S
required
Topical
LWS-MI-TR-AT-THM
524
Temporary relief of pain associated with
acute gout.
Warning S
required
Oral
M10-PA-RE-TE-S00
525
Helps improve joint mobility associated
with arthritis
Warning S
required
Oral
M13-JM-IM-HE-S00
ARTH4
May help increase joint mobility associated with
arthritis
526
Traditional herbal medicinal product for
relief of mild joint pain
Warning S
required
Oral
M13-MI-RE-00-THM
EMA
Traditional herbal medicinal product for relief of
minor articular pain
527
Relieves symptoms of medically diagnosed
osteoarthritis.
Warning S2
required
Oral
M15-SY-RE-00-S00
RHEUM1
Symptomatic relief of osteoarthritis.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 68 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
528
Assists in the management of medically
diagnosed osteoarthritis.
Warning S2
required
Oral
M15-00-MG-AS-S00
529
Assists in the management of the pain of
medically diagnosed osteoarthritis.
Warning S2
required
Oral
M15-PA-MG-AS-S00
530
Helps reduce joint inflammation
associated with arthritis.
Warning S
required
Oral
M19-JI-RD-HE-S00
ARTH2
May help reduce joint inflammation associated
with arthritis.
531
Helps reduce joint swelling associated
with arthritis.
Warning S
required
Oral
M19-JS-RD-HE-S00
ARTH3
May help reduce joint swelling associated with
arthritis.
Temporary relief of the pain of arthritis.
Warning S
required
Oral
M19-PA-RE-TE-S00
ARTH1
Temporary relief of the pain of arthritis. (or)
Temporary relief of arthritic pain.
533
Temporary relief of the pain of medically
diagnosed osteoarthritis.
Warning S2
required
Oral
M19-PA-RE-TE-SOA
534
Traditional herbal medicinal product for
the relief of mild joint pain
Warning S
required
Oral
M25-MI-RE-00-THM
Traditional herbal medicinal product
[used]to assist in the relief of minor
muscular and joint pain
Warning S
required
Topical
Herbal medicinal product used for the
short-term management of low back pain
Warning S
required
Oral
532
535
536
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Source
Source indication
RHEUM3
May assist in the management of osteoarthritis.
RHEUM5
May assist in the management of osteoarthritic
pain.
OSAR
Temporary relief of the pain of osteoarthritis (or)
Temporary relief of osteoarthritic pain.
EMA
Traditional herbal medicinal product for the relief
of minor articular pain
M25-MI-RE-AS-THM
EMA
Traditional herbal medicinal product as an
adjuvant in the relief of minor muscular and
articular pain and in minor peripheral circulatory
disorders
M45-00-MG-ST-NHM
EMA
Herbal medicinal product used for the short-term
treatment of low back pain
Page 69 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
537
Assists in the management of lower back
pain
Warning S
required
Oral
Relieves the symptoms of low back pain
Warning S
required
Temporary relief of lower back pain
540
Source
Source indication
M54-00-MG-AS-S00
SKEL2/MU
SC13
May assist in the management of low back pain. /
May assist in the management of low back pain.
Oral
M54-00-RE-00-S00
MUSC8/SK
EL1
For the symptomatic relief of low back pain. / For
the symptomatic relief of low back pain.
Warning S
required
Oral
M54-00-RE-TE-S00
NERV8
Temporary relief of lower back pain.
Assists in the management of the
symptoms of sciatica.
Warning S
required
Oral
M54-SY-MG-AS-S00
NERV19
May assist in the management of sciatica.
541
Temporary relief of the painful symptoms
of sciatica.
Warning S
required
Oral
M54-PS-RE-TE-S00
NERV7
Temporary relief of the painful symptoms of
sciatica and whiplash.
542
Relief of the pain of medically diagnosed
sciatica.
Warning S2
required
Oral
M54-PA-RE-00-S00
SCIAT
Relief of the pain of sciatica.
543
Assists in the management of medically
diagnosed tenosynovitis.
Warning S2
required
Oral
M70-00-MG-AS-S00
MUSC12
May assist in the management of tenosynovitis.
544
Relieves the symptoms of medically
diagnosed tenosynovitis.
Warning S2
required
Oral
M70-SY-RE-00-S00
MUSC7
For the symptomatic relief of tenosynovitis.
Relieves muscular aches and pains
Warning S
required
Oral/Topical
M79-AP-RE-00-S00
MUSC1
Relief of muscular aches and pains.
538
539
545
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 70 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
546
547
548
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Used in herbal medicine as supportive
therapy to help relieve rheumatic
complaints
Warning S
required
Oral
M79-CO-RE-HE-NHM
HC
Used in Herbal Medicine as supportive therapy to
help relieve rheumatic complaints
Traditionally used in herbal medicine to
help relieve mild joint pain and
inflammation
Warning S
required
Oral
M79-JP-RE-HE-THM
HC
Traditionally used in Herbal Medicine as an antiinflammatory to help relieve joint pain
Relieves the symptoms of localised muscle
pain
Warning S
required
Topical
M79-LO-RE-SY-S00
EMA
For the symptomatic relief of localised muscle pain
549
550
551
552
Traditionally used in herbal medicine (as a
rubefacient/counterirritant) to help
relieve muscle pain
Warning S
required
Topical
M79-MP-RE-HE-THM
HC
Traditionally used in Herbal Medicine (as a
rubefacient/counterirritant) to help relieve the
symptoms of rheumatism and/or muscle and joint
pain (Blumenthal et al. 2000, Lust 1987, BHP 1983,
Ellingwood 1983[1919], Felter and Lloyd
1983[1898], Felter 1983[1922], BPC 1934)
Traditionally used in herbal medicine to
help alleviate the pain associated with
rheumatism
Warning S
required
Oral
M79-PA-AL-HE-THM
HC
Traditionally used in Herbal Medicine to help
alleviate the pain associated with rheumatism
Traditionally used in herbal medicine to
help temporarily relieve pain and/or
inflammation in muscles and joints (e.g.
sprains, bruises, mild joint pain)
Warning S
required
Topical
M79-PI-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve pain and/or inflammation in muscles and
joints (e.g. sprains, bruises, joint pain) (Bradley
2006; ESCOP 2003; Grieve 1971 [1931]).
Traditionally used in herbal medicine (as a
rubefacient/counterirritant) to help
Warning S
required
Topical
M79-SY-RE-HE-THM
HC
Traditionally used in Herbal Medicine (as a
rubefacient/counterirritant) to help relieve the
symptoms of rheumatism and/or muscle and joint
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 71 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
relieve the symptoms of rheumatism
Source indication
pain (Blumenthal et al. 2000, Lust 1987, BHP 1983,
Ellingwood 1983[1919], Felter and Lloyd
1983[1898], Felter 1983[1922], BPC 1934)
553
Relief of the pain of fibrositis.
Warning S
required
Oral or
topical
M79-PA-RE-00-S00
554
Relieves the symptoms of medically
diagnosed fibromyalgia.
Warning S2
required
Oral
M79-SY-RE-00-S00
555
Assists in the management of medically
diagnosed fibromyalgia.
Warning S2
required
Oral
M79-00-MG-AS-S00
556
Relieves mild nerve pain/mild neuralgia.
Warning S
required
Oral
M79-NE-RE-00-S00
538
Temporary relief of the pain of
rheumatism
Warning S
required
Oral
M79-PA-RE-TE-S00
557
Temporary relief of rheumatic pain.
Warning S
required
Oral
M79-RP-RE-TE-S00
558
Assists in the management of medically
diagnosed osteoporosis.
Warning S2
required
Oral
M85-00-MG-AS-S00
559
Assists in the prevention of osteoporosis.
Warning S
required
Oral
M85-CO-PV-AS-S00
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
FIBR
Relief of the pain of fibrositis.
MUSC4
For the symptomatic relief of fibromyalgia.
MUSC9
May assist in the management of fibromyalgia.
NERV9
For relief of nerve pain/mild neuralgia.
RHEUM
Temporary relief of the pain of rheumatism. [or]
Temporary relief of rheumatic pain.
RHEUM
Temporary relief of the pain of rheumatism. [or]
Temporary relief of rheumatic pain.
OSPOR1
Source of calcium. May assist in the prevention
and/or treatment of osteoporosis.
OSPOR1
Source of calcium. May assist in the prevention
and/or treatment of osteoporosis.
Page 72 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
560
Assists in the management of medically
diagnosed osteoporosis in post
menopausal women.
Warning S2
required
Assists in the prevention of osteoporosis
in post menopausal women.
Warning S
required
561
Route of
admin
Oral
Oral
Target-QT-action-QAcontext
Source
Source indication
OSPOR2
Source of calcium. Women's calcium requirements
are increased after menopause. Calcium
supplementation may be of assistance in the
prevention and/or treatment of osteoporosis.
OSPOR2
M85-00-PV-AS-SPW
Source of calcium. Women's calcium requirements
are increased after menopause. Calcium
supplementation may be of assistance in the
prevention and/or treatment of osteoporosis.
M85-00-MG-AS-SPW
562
Helps in the development and
maintenance of bones
Oral
MBO-00-DM-HE-S00
HC
Helps in the development and maintenance of
bones/Source of vitamin A to help in the
development and maintenance of
bones/Provitamin A to help in the development
and maintenance of bones
563
Helps bone formation
Oral
MBO-00-FO-HE-S00
FNFC
Helps bone formation
564
Helps in the maintenance of bones.
Oral
MBO-00-MA-HE-S00
HC
Helps in the maintenance of bones.
565
Adequate dietary calcium in our youth and
throughout life is required to maximise
bone.
Oral
MBO-00-MX-00-S00
CALC3
Source of calcium. Adequate dietary calcium in our
youth and throughout life is required to maximise
bone.
HC
Helps to attenuate/reduce bone mineral density
(BMD) loss in post-menopausal women when used
in conjunction wtih adequate amounts of calcium
and vitamin D
566
Helps to attenuate/reduce bone mineral
density (BMD) loss in post-menopausal
women when used in conjunction with
adequate amounts of calcium and vitamin
D
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Oral
MBO-DL-AR-HE-SPM
Page 73 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
567
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Helps in the development and
maintenance of bones and teeth (optional:
"especially in childhood, adolescence and
young adulthood").
Oral
MBO-GR-AI-00-S00
FNFC
Aids in the growth of bone
568
Helps maintain healthy bones / bone
health
Oral
MBO-HE-MA-HE-S00
BM05
Maintain bone health
569
Helps in the development of healthy
cartilage
Oral
MCA-00-DM-HE-S00
HC
Helps in the development and maintenance of
cartilage
570
Helps to protect against the deterioration
of cartilage
Oral
MCA-DE-PR-HE-S00
HC
Helps to protect against the deterioration of
cartilage
571
Supports the growth of healthy joint
cartilage
Oral
MCA-GR-SU-00-S00
SAN05
For growth and maintenance of healthy cartilage
572
Helps to support cartilage integrity in
healthy individuals
Oral
MCA-GR-SU-HE-S00
BM19
Helps reduce cartilage wear/Helps reduce further
damage and/or loss of cartilage
573
Helps in maintaining healthy cartilage
Oral
MCA-HE-MA-HE-S00
HC
A factor in maintaining healthy cartilage
574
Supports healthy joint function
Oral
MFU-JO-SU-00-S00
SAN03
Maintains / Improve joint function
Helps in maintaining joint health
Oral
MJO-HE-MA-00-S00
HC
A factor in maintaining joint health/ Helps to
maintain joint health
575
Label
disclaimers
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 74 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
576
Used in herbal medicine to help relieve
mild joint inflammation
Warning S
required
Oral
MJO-IN-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve joint
inflammation
577
Relief of the pain and burning sensation of
cystitis.
Warning CYST
required
Oral
N30-PB-RE-00-S00
578
Relieves the symptoms of medically
diagnosed benign prostatic hypertrophy.
Warning S2
required
Oral
N40-SY-RE-00-S00
Relieves the symptoms of vaginal itch.
Warning S
required
Topical
Assists in the management of heavy
periods
Warning S
required
Relieves heavy periods
579
580
581
582
583
584
CYST
Relief of the pain and burning sensation associated
with cystitis.
MALE4
For the symptomatic relief of medically diagnosed
benign prostatic hypertrophy.
N76-00-RE-00-S00
VAG3
For the symptomatic relief of vaginal itch.
Oral
N92-HE-MG-AS-S00
MENS11
May assist in the management of heavy periods.
Warning S
required
Oral
N92-HE-RE-00-S00
MENS7
For the symptomatic relief of heavy periods.
Assists in the management of irregular
periods
Warning S
required
Oral
N92-IR-MG-AS-S00
MENS12
May assist in the management of irregular periods.
Relieves irregular periods
Warning S
required
Oral
N92-IR-RE-00-S00
MENS8
For the symptomatic relief of irregular periods
Traditionally used in herbal medicine to
help relieve the pain associated with
menstruation
Warning S
required
Oral
N94-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve the pain associated with menstruation
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 75 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Relieves pre-menstrual breast pain
Warning S
required
Oral
N94-BP-RE-00-S00
MENS4
Relief of pre-menstrual breast pain.
Relief of menstrual cramps.
Warning S
required
Oral
N94-CR-RE-00-S00
MENS2
Relief of menstrual cramps.
587
Assists in the management of
dysmenorrhoea
Warning S
required
Oral
N94-DM-MG-AS-S00
MENS10
May assist in the management of dysmenorrhoea.
588
Traditional herbal medicinal product for
the reduction of heavy menstrual bleeding
in women with regular menstrual cycles,
after serious conditions have been
excluded by a medical doctor
Warning S
required
Oral
N94-HE-RE-00-THM
EMA
Traditional herbal medicinal product for the
reduction of heavy menstrual bleeding in women
with regular menstrual cycles, after serious
conditions have been excluded by a medical doctor
Used in herbal medicine as a hormone
normaliser to help stabilise menstrual
cycle irregularities
Warning S
required
Oral
N94-IR-SB-HE-NHR
HC
Used in Herbal Medicine as a hormone normaliser
to help stabilise menstrual cycle irregularities
Traditional herbal medicinal product for
symptom management of minor spasm
associated with menstrual periods
Warning S
required
Oral
N94-MI-MG-SY-THM
EMA
Traditional herbal medicinal product for
symptomatic treatment of minor spasm associated
with menstrual periods
Traditional herbal medicinal product for
the relief of minor symptoms in the days
before menstruation (premenstrual
syndrome)
Warning S
required
Oral
N94-MS-RE-00-THM
EMA
Traditional herbal medicinal product for the relief
of minor symptoms in the days before
menstruation (premenstrual syndrome)
Used in Traditional Chinese Medicine
Warning S
Oral
N94-PA-RE-00-TCM
HC
Used in TCM to eliminate blood stasis, promote the
585
586
589
590
591
592
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 76 of 92
Therapeutic Goods Administration
Ref
No
593
Proposed permitted indication
Label
disclaimers
(TCM) to relieve pain of menstruation due
to blood stasis
required
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
flow of qi and relieve pain of menstruation due to
blood stasis
Relieves menstrual pain/cramps
Warning S
required
Oral
N94-PC-RE-00-S00
MENS1
Relief of menstrual pain.
594
Assists in the management of premenstrual tension/syndrome
Warning S
required
Oral
N94-PM-MG-AS-S00
MENS9
May assist in the management of pre-menstrual
tension/syndrome.
595
Traditionally used in herbal medicine to
help relieve the pain associated with
menstruation
Warning S
required
Oral
N94-PM-RE-HE-THM
HC
(Traditionally) used in Herbal Medicine to help
relieve the pain associated with menstruation
Relieves the symptoms of pre-menstrual
syndrome
Warning S
required
Oral
N94-PS-RE-00-S00
PMS/MEN
S5
Relief of pre-menstrual symptoms/syndrome
Used in herbal medicine to help relieve
premenstrual symptoms
Warning S
required
Oral
N94-PS-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve
premenstrual symptoms (Blumenthal et al. 2000,
Bradley 1992)
Relieves the symptoms of dysmenorrhoea
Warning S
required
Oral
N94-SD-RE-00-S00
MENS6
For the symptomatic relief of dysmenorrhoea.
Relieves menstrual symptoms
Warning S
required
Oral
N94-SM-RE-00-S00
MENS3
Relief of menstrual symptoms.
Relieves the symptoms of pre-menstrual
tension
Warning S
required
Oral
N94-SP-RE-00-S00
MENS5
For the symptomatic relief of pre-menstrual
tension/syndrome.
596
597
598
599
600
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 77 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
601
Relieves vaginal dryness and discomfort
by local application
Warning S
required
Oral
N94-VD-RE-00-S00
VAG1
Relief of vaginal dryness/discomfort by local
application.
Assists in the management of menopause
Warning S
required
Oral
N95-00-MG-AS-S00
MENO4
May assist in the management of menopause.
Herbal medical product for the relief of
menopausal complaints such as hot
flushes and profuse sweating
Warning S
required
Oral
N95-CO-RE-00-NHM
EMA
Herbal medical product for the relief of
menopausal complaints such as hot flushes and
profuse sweating
604
Relieves hot flushes associated with
menopause
Warning S
required
Oral
N95-HF-RE-00-S00
MENO2
Relief of hot flushes associated with menopause
605
Reduces severity and frequent
menopausal symptoms (such as hot
flushes and/or night sweats)
Warning S
required
Oral
N95-SF-RE-00-S00
HC
May reduce severe and frequent menopausal
symptoms (such as hot flashes and/or night
sweats)
Relief of menopausal symptoms.
Warning S
required
Oral
N95-SY-RE-00-S00
MENO1/3
Relief of menopausal symptoms. / For the
symptomatic relief of menopause.
Used in herbal medicine to help relieve
symptoms associated with menopause
Warning S
required
Oral
N95-SY-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve symptoms
associated with menopause
EMA
Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing of
the urinary tract as an adjuvant in minor urinary
tract complaints
602
603
606
607
608
Traditional herbal medicinal product used
as an adjuvant in minor urinary tract
complaints
Warning CYST
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Oral
NCO-MI-US-AD-THM
Page 78 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
609
610
611
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Helps to support prostate health
Oral
NPR-HE-SU-HE-S00
HC
Helps to support prostate health
Supports production of healthy sperm
Oral
NSP-HE-PD-SU-S00
BM04
Supports production of healthy sperm
Traditional herbal medicinal product used
to increase the amount of urine to achieve
flushing of the urinary tract
Warning
LAX1, LAX2 &
LAX3?
Oral
NUT-FL-US-00-THM
EMA
Traditional herbal medicinal product used to
increase the amount of urine to achieve flushing of
the urinary tract as an adjuvant in minor urinary
tract complaints
612
Relieves [symptoms] of morning sickness
(e.g., nausea / vomiting)
Warning S
required
Oral
O21-00-RE-00-S00
BM11
Helps relieve the symptoms of morning sickness
such as nausea and vomiting
613
A daily dose of 400-500mcg of folic acid or
folate, if taken daily for one month before
conception and during the first trimester
of pregnancy - reduces the risk of women
having a child with birth defects of the
brain such as anencephaly or spinal cord
such as the neural tube defect known as
spina bifida.
Warning
NEUR
required, NS1
A daily dose of 400-500mcg of folic acid or
folate, if taken daily for one month before
conception and during the first trimester
of pregnancy - reduces the risk of having a
child with spina bifida/neural tube
defects.
Warning
NEUR
required, NS1
Relief of coughs
Warning S,
COU1 & COU2
614
615
Oral
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
NEUR1
Provides a daily dose of 400-500mcg of folic acid or
folate. Contains folic acid which - if taken daily for
one month before conception and during
pregnancy - may reduce the risk of women having a
child with birth defects of the brain and/or spinal
chord such as the neural tube defects known as
spina bifida and anencephaly.
NEUR2
Provides a daily dose of 400-500mcg of folic acid or
folate. Contains folic acid which - if taken daily for
one month before conception and during
pregnancy - may reduce the risk of having a child
with spina bifida/neural tube defects.
COU2
Relief of coughs
Q07-CO-PV-RR-S00
Oral
Q07-CO-PV-RR-S00
Oral
R05-00-RE-00-S00
Page 79 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
required
616
617
618
619
620
621
Temporary relief of cough
Warning S,
COU1 & COU2
required
Oral
R05-00-RE-TE-S00
COU1
Temporary relief of coughs
Traditionally used in herbal medicine to
help relieve coughs (spasmolytic)
Warning S,
COU1 & COU2
required
Oral
R05-SP-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve coughs (spasmolytic)
For temporary relief of cough.
For the relief of cough.
Temporary relief of chest cough
Temporary relief of cough due to throat
irritation
Warnings
COU1 and
COU2
required
Warnings
COU1 and
COU2
required
Warnings
COU1 and
COU2
required
Warnings
COU1 and
COU2
required
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Oral
Oral
Oral
Oral
BRCH1
Temporary relief of the cough of bronchitis. (or)
Temporary relief of bronchial cough.
BRCH2
Relief of the cough of bronchitis. (or) Relief of
bronchial cough.
BRCH3
Temporary relief of cough due to bronchial
congestion.
BRCH4
Temporary relief of cough due to bronchial
irritation.
R05-CO-RE-TE-S00
R05-CO-RE-00-S00
R05-CO-RE-TE-CH
R05-TI-RE-TE-S00
Page 80 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
622
623
624
625
626
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used in herbal medicine to
help relieve intestinal colic
(antispasmodic)
Warning S
required
Oral
R10-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve intestinal colic (antispasmodic)
Used in herbal medicine to help relieve
abdominal pain and burning sensation in
the stomach
Warning S
required
Oral
R10-BS-RE-HE-NHM
HC
Used in Herbal Medicine to help relieve abdominal
pain and burning sensation in the stomach
Traditionally used in herbal medicine to
help prevent nausea (anti-emetic)
Warning S
required
Oral
R11-00-PV-HE-THM
HC
Traditionally used in Herbal Medicine to help
prevent nausea (anti-emetic) (Bradley 1992,
Williamson et al. 1988)
Traditionally used in herbal medicine to
help relieve nausea and vomiting
Warning S
required
Oral
R11-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve nausea and vomiting
Helps prevent symptoms associated with
motion sickness (nausea, vomiting)
Warning S
required
Oral
R11-MO-PV-HE-S00
HC
(Clinically shown to) help(s) prevent nausea and
vomiting associated with motion sickness, and/or
seasickness
Assists in the management of heartburn
Warning S
required
Oral
R12-00-MG-AS-S00
GAST9
May assist in the management of heartburn
Relieves symptoms of heartburn
Warning S
required
Oral
R12-SY-RE-00-S00
GAST4
For the symptomatic relief of heartburn
Traditionally used in herbal medicine to
help expel intestinal gas (a carminative)
Warning S
required
Oral
R14-00-EX-HE-T00
HC
Traditionally used to help expel intestinal gas (a
carminative) (Hoffman 1996; Felter and Lloyd
1983).
627
628
629
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 81 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
630
631
632
633
634
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used in herbal medicine to
help relieve flatulence/to help expel
intestinal gas (carminative)
Warning S
required
Oral
R14-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve flatulence/to help expel intestinal gas
(carminative)
Assists in the management of flatulence
Warning S
required
Oral
R14-FL-MG-AS-S00
FLAT2/4
Aids or assists in the treatment of flatulence
Reduces flatulence
Warning S
required
Oral
R14-FL-RD-00-S00
FLAT1
Aids or assists in the relief of flatulence
Assists in the relief of flatulence
Warning S
required
Oral
R14-LT-RE-AS-S00
FLAT3
Liver tonic. Aids or assists in the relief of flatulence
Oral
R19-HA-MG-AS-S00
DENT8
May assist in the management of halitosis
Assists in the management of halitosis
635
636
637
Traditionally used in herbal medicine as
an astringent to relieve symptoms of
localized inflamed swellings
Warning S
required
Oral
R22-AS-RE-00-THM
HC
Traditionally used as an astringent to relieve
symptoms of haemorrhoids, damaged veins
(varicose veins), bruises and localized inflamed
swellings. (Jellin et al. 2003; Bisset and Wichtl
2001; Blumenthal et al. 2000; Foster 1998;
Moerman 1998; Chevallier 1996; Leung and Foster
1996).
Assists in the prevention of muscular
cramps and spasms
Warning S
required
Oral
R25-00-PV-AS-S00
MUSC3
Aids or assists in the prevention of muscular
cramps and spasms.
Relieves muscular cramps and spasms
Warning S
required
Oral
R25-00-RE-00-S00
MUSC2
Relief of muscular cramps and spasms.
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 82 of 92
Therapeutic Goods Administration
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used herbal medicine to
relieve nervousness (calmative/sedative)
Warning S
required
Oral
R45-00-AI-00-TWH
HC
Traditionally used (in Western herbalism) to
relieve nervousness (calmative/sedative)
(Ellingwood 1983; Felter 1983; BHP 1983).
Relieves irritability
Warning S
required
Oral
R45-00-RE-00-S00
NERV10
For the relief of irritability.
Improves stress adaptation.
Warning S
required
Oral
R45-AD-IM-00-S00
NERV5
Non-vitamin active ingredients may improve stress
adaptation.
641
Traditionally used in herbal medicine to
help ease nervous tension (calmative)
Warning S
required
Oral
R45-CA-EA-HE-THM
HC
(Traditionally) used in Herbal Medicine to help
ease nervous tension (calmative)
642
Traditionally used in herbal medicine to
help relieve nervousness (nervine)
Warning S
required
Oral
R45-NE-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve Nervousness (nervine)
643
Traditionally used in herbal medicine as a
nervine to help relieve nervousness and
restlessness
Warning S
required
Oral
R45-NR-RE-HE-THM
HC
Traditionally used in Herbal Medicine as a nervine
to help relieve nervousness and restlessness
Traditionally used in herbal medicine to
help relieve nervousness (as mild
sedative)
Warning S
required
Oral
R45-SE-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve nervousness (as mild sedative)
645
Traditional herbal medicinal product used
to relieve symptoms of nervous tension
Warning S
required
Oral
R45-SY-RE-00-THM
EMA
Traditional herbal medicinal product used to
relieve symptoms of nervous tension
646
Helps relieve nervous unrest.
Warning S
Oral
R45-UN-RE-HE-S00
NERV11
Helps relieve nervous unrest.
Ref
No
638
639
640
644
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 83 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Warning S
required
Oral
R45-00-RE-HE-S00
NERV1
Helps relieve nervous tension, stress and mild
anxiety.
Traditionally used to reduce fever
Warning S
required
Oral
R50-00-RD-00-T00
HC
Traditionally used to reduce fever (Moerman
1998).
Traditionally used in herbal medicine to
help reduce fever (febrifuge)
Warning S
required
Oral
R50-00-RD-HE-THM
HC
Traditionally used in Herbal Medicine to help
reduce fever (febrifuge) (Williamson et al. 1988,
BHP 1983, Grieve 1971[1931])
Traditionally used in herbal medicine to
help relieve fever by inducing sweating
(diaphoretic)
Warning S
required
Oral
R50-00-RE-HE-THM
HC
Traditionally used in Herbal Medicine to help
relieve feverish conditions by inducing sweating
(diaphoretic) (Bradley 2006, Grieve 1971[1931])
Traditional herbal medicinal product used
for the relief of fever associated with
common cold
Warning S &
COLD
required
Oral
R50-CC-RE-00-THM
EMA
Traditional herbal medicinal product used for the
relief of fever associated with common cold
Traditional herbal medicinal product used
for the relief of headache
Warning S
required
Oral
R51-00-RE-00-THM
EMA
Traditional herbal medicinal product used for the
relief of headache
Temporary relief of headache
Warning S
required
Oral
R51-00-RE-TE-S00
HEAD1
Temporary relief of headaches.
Traditionally used in Traditional Chinese
Medicine (TCM) to relieve pain
Warning S
required
Oral
R52-00-RE-00-TCM
HC
Traditionally used in TCM to relieve pain (Long
1998, Bensky and Gamble 1993)
required
647
648
649
650
651
652
653
654
Helps relieve nervous tension
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 84 of 92
Therapeutic Goods Administration
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Used in herbal medicine to reduce mental
fatigue in cases of mental stress
Warning S
required
Oral
R53-00-RD-00-NHM
HC
(Used in Herbal Medicine to) help(s) support
cognitive function and/or reduce mental fatigue (in
cases of mental stress)
Helps temporarily to relieve fatigue, to
promote endurance, and to enhance motor
performance
Oral
R53-00-RE-HE-S00
HC
Helps (temporarily) to relieve fatigue, to promote
endurance, and to enhance motor performance
Temporarily supports alertness and
wakefulness
Oral
R53-00-SU-TE-S00
HC
Helps (temporarily) to promote alertness and
wakefulness, and to enhance cognitive
performance
Traditionally used in Ayurveda to relieve
general debility, especially during
convalescence or old age
Oral
R53-GE-RE-00-TAY
HC
Traditionally used in Ayurveda to relieve general
debility, especially during convalescence or old age
(API 2001, Kapoor 2001)
659
Helps relieve the daytime fatigue
associated with jet lag
Oral
R53-JL-RE-HE-S00
HC
Helps relieve the daytime fatigue associated with
jet lag
660
Traditional herbal medicinal product for
symptoms of asthenia such as fatigue and
weakness
Oral
R53-SY-FO-00-THM
EMA
Traditional herbal medicinal product for symptoms
of asthenia such as fatigue and weakness
Traditional herbal medicinal product for
symptoms of fatigue and sensation of
weakness
Oral
R53-SY-FR-00-THM
EMA
Traditional herbal medicinal product for symptoms
of fatigue and sensation of weakness
Used in herbal medicine as a tonic to help
relieve general debility
Oral
R53-TO-AI-00-NHM
HC
Used in Herbal Medicine as a tonic to help relieve
general debility and/or to aid during convalescence
Ref
No
655
656
657
658
661
662
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 85 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
663
Assists in the management of fluid
retention.
Warning
FLRET
required
Oral
R60-00-MG-AS-S00
Helps temporarily to promote alertness
and wakefulness, and to enhance cognitive
performance
Oral
Helps to decrease cognitive fatigue due to
physically stressful situations (e.g.
Extended wakefulness, exposure to cold,
excessive noise)
664
665
666
669
Source indication
FLRET1
Aids or assists in the treatment of fluid retention.
RAW-00-PR-HE-S00
HC
Helps (temporarily) to promote alertness and
wakefulness, and to enhance cognitive
performance
Oral
RCF-PS-DE-HE-S00
HC
Helps to decrease cognitive fatigue due to
physically stressful situations (e.g. Extended
wakefulness, exposure to cold, excessive noise)
Traditionally used in herbal medicine as
an expectorant to relieve coughs and other
affections of the chest
Warning S,
COU1 & COU2
required
Oral
REX-CC-US-00-T00
HC
Traditionally used as an expectorant to relieve
coughs and other affections of the chest (Moerman
1998; Felter and Lloyd 1983).
Traditional herbal medicinal product used
as an expectorant in cough and cold
Warning S,
COLD, COU1 &
COU2
required
Oral
REX-CC-US-00-THM
EMA
Traditional herbal medicinal product used as an
expectorant in cough and cold
Traditional herbal medicinal product used
as an expectorant in cough associated with
cold
Warning S,
COLD, COU1 &
COU2
required
Oral
REX-CO-US-00-THM
EMA
Traditional herbal medicinal product used as an
expectorant in cough associated with cold
Traditionally used in herbal medicine as
an expectorant to help relieve cold
Warning S,
COLD, COU1 &
COU2
Oral
REX-CS-US-00-THM
HC
Traditionally used in Herbal Medicine as an
expectorant to help relieve cold symptoms such as
667
668
Source
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 86 of 92
Therapeutic Goods Administration
Ref
No
670
671
672
655
Proposed permitted indication
Label
disclaimers
symptoms such as excessive catarrh
required
Traditionally used in herbal medicine as
an expectorant to help relieve excess
mucous of the respiratory passages (anticatarrhal)
Warning S
required
Oral
REX-MU-US-00-THM
HC
Traditionally used in Herbal Medicine as an
expectorant to help relieve excess mucous of the
respiratory passages (anti-catarrhal)
Herbal medicinal product used as an
expectorant in case of productive cough
Warning S,
COU1 & COU2
required
Oral
REX-PC-US-00-THM
EMA
Herbal medicinal product used as an expectorant in
case of productive cough
Traditionally used in herbal medicine as
an expectorant to help relieve coughs
associated with cold
Warning S,
COLD, COU1 &
COU2
required
Oral
REX-RC-US-00-THM
HC
Traditionally used in Herbal Medicine as an
expectorant to help relieve coughs associated with
cold
Used in herbal medicine to help improve
mental and/or physical performance after
periods of mental and/or physical
exertion
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
excessive catarrh
Oral
RPE-MP-IM-HE-NHM
HC
Used in Herbal Medicine to help improve mental
and/or physical performance after periods of
mental and/or physical exertion (Bradley 2006,
ESCOP 2003, Hoffmann 2003, Mills and Bone 2000)
656
Traditionally used in herbal medicine to
relieve symptoms of pruritus
Warning S
required
Topical
RPR-SY-RE-HE-THM
HC
Traditonally used in Herbal Medicine to relieve
symptoms of pruritus (Hoffmann 2003, BHP 1983)
657
Traditionally used in Traditional Chinese
Medicine (TCM) to reduce swelling
Warning S
required
Topical
RSW-00-RD-00-TCM
HC
Traditionally used in TCM to reduce swelling (Long
1998, Bensky and Gamble 1993)
Assists in the management of sprains
Warning S
required
Topical
T14-00-MG-AS-S00
MUSC10
May assist in the management of sprains.
658
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 87 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
659
660
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditional herbal medicinal product used
for symptomatic management of insect
bites
Warning S
required
Topical
T14-IB-MG-SY-THM
EMA
Traditional herbal medicinal product used for
symptomative treatment of insect bites
Traditional herbal medicine product for
symptomatic management of bruises and
sprains
Warning S
required
Topical
T14-BR-MG-SY-THM
EMA
Tradtional herbal medicinal product for
symptomatic treatment of bruises and sprains
661
Traditionally used in herbal medicine as
an astringent to relieve symptoms of
bruises
Warning S
required
Topical
T14-AS-RE-SY-THM
HC
Traditionally used as an astringent to relieve
symptoms of haemorrhoids, damaged veins
(varicose veins), bruises and localized inflamed
swellings. (Jellin et al. 2003; Bisset and Wichtl
2001; Blumenthal et al. 2000; Foster 1998;
Moerman 1998; Chevallier 1996; Leung and Foster
1996).
662
Assists in the management of minor skin
wounds (e.g., cuts / scratches / abrasions)
Warning S
required
Topical
T14-MI-MG-AS-S00
SKIN15
May assist in the management of minor wounds
(cuts, scratches, abrasions)
663
Traditionally used in herbal medicine as
an antimicrobial to help manage and heal
minor skin wounds, cuts, burns and
bruises
Warning S
required
Topical
T14-MI-TR-AM-THM
HC
Traditionally used in Herbal Medicine as an
antiseptic and/or antimicrobial to help treat and
heal minor skin wounds, cuts, burns and bruises
Traditionally used in herbal medicine as
an antiseptic to help manage and heal
minor skin wounds, cuts, burns and
bruises
Warning S
required
Topical
T14-MI-TR-AT-THM
HC
Traditionally used in Herbal Medicine as an
antiseptic and/or antimicrobial to help treat and
heal minor skin wounds, cuts, burns and bruises
664
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 88 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
665
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Traditionally used to temporarily relieve
the pain and reduce discoloration caused
by bruises
Warning S
required
Topical
T14-PD-RD-00-T00
HC
Traditionally used to reduce pain and discoloration
caused by bruises (Bartram 1995; Grieve 1971).
Traditional herbal medicinal product for
relief of signs of bruises, such as local
oedema and haematoma
Warning S
required
Oral
T14-SI-RE-00-THM
EMA
Tradition herbal medicinal product for relief of
signs of bruises, such as local oedema and
haematoma
Relieves the symptoms of sprains
Warning S
required
Topical
T14-SP-RE-00-S00
MUSC5
For the symptomatic relief of sprains.
668
Relieves symptoms of minor wounds (cuts
- scratches - abrasions).
Warning S
required
Topical
T14-SW-RE-SY-S00
SKIN7
For the symptomatic relief of minor wounds (cuts scratches - abrasions).
669
For the management of minor skin
disorders such as wounds, scratches,
bruising, cuts and abrasions.
Warning S
required
Oral or
topical
T14-00-MG-00-S00
666
667
670
671
672
SKIN19
Treatment of minor skin disorders such as wounds,
scratches, eczema, dermatitis, bruising, cuts and
abrasions.
Traditionally used in herbal medicine to
help relieve minor burns including
sunburn
Warning S
required
Topical
T20-MI-RE-HE-THM
HC
(Traditionally) used in Herbal Medicine to help
relieve minor burns including sunburn
Relieves symptoms of chilblains
Warning S
required
Topical
T69-SY-RE-00-S00
CHILB
Relief of the symptoms of chilblains
Used in Traditional Chinese Medicine
(TCM) to relieve symptoms of thirst due to
impairment of body fluids and internal
heat
Warning S
required
Oral
T73-SY-RE-00-TCM
HC
Used in TCM to reinforce qi, benefit the spleen and
lung, relieve symptoms of thirst due to impairment
of body fluids and internal heat
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 89 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
673
Assists in the management of motion
sickness
Warning S
required
Oral
T75-00-MG-AS-S00
TRAV
Assists in the management of motion sickness
Relieves symptoms of motion sickness
Warning S
required
Oral
T75-MS-RE-00-S00
BM18
Helps relieve the symptoms of motion sickness
such as nausea, vomiting and cold sweats
Assists in the management of minor
allergy
Warning S
required
Oral
T78-00-MG-AS-S00
ALLER3
May assist in the management of allergies
Relieves the symptoms of allergies
Warning S
required
Oral
T78-SY-RE-00-S00
ALLER/1
Relief of the symptoms of allergies
Oral
Z54-TO-AI-00-NHM
HC
Used in Herbal Medicine as a tonic to help relieve
general debility and/or to aid during convalescence
674
675
676
677
678
Used in herbal medicine as a tonic to aid
during convalescence
Beneficial during times of stress.
Warning S
required
Oral
Z73-00-BE-00-S00
NERV2/4
Beneficial during times of stress.
679
Relieves symptoms of study or workrelated stress
Warning S
required
Oral
Z73-00-RE-HE-NHM
NERV6
Herbal blend which helps relieve stress of study or
work.
680
Traditional herbal medicinal product for
relief of mild symptoms of mental stress
Warning S
required
Oral
Z73-SY-RE-00-THM
EMA
Traditional herbal medicinal product for relief of
mild symptoms of mental stress
681
Traditionally used in herbal medicine as a
liver tonic
Oral
KTO-LT-US-00-THM
FLAT4
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 90 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
682
683
Label
disclaimers
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Antioxidant
Oral
0AO-00-US-00-S00
SAN08
Antioxidant
Traditionally used in herbal medicine as a
mild antiseptic
Topical
0AT-MI-US-00-THM
HC
Traditionally used in Herbal Medicine as a mild
antiseptic
684
Helps strengthen bone and tissue in
growing and mature users.
Oral
0BS-00-SN-00-SCO
CALC2
Source of calcium. A calcium supplement
formulated to strengthen bone and tissue in
growing and mature users. (or) Source of calcium.
A calcium supplement formulated to strengthen
bone and tissue for children and older adults.
Helps in the development and
maintenance of bones and teeth
Oral
0BT-00-DM-HE-S00
HC
Helps in the development and maintenance of
bones and teeth (optional: "especially in childhood,
adolescence and young adulthood").
Helps in the development and
maintenance of bones and teeth especially
in childhood, adolescence and young
adulthood
Oral
0BT-00-DM-HE-SCA
HC
Helps in the development and maintenance of
bones and teeth especially in childhood,
adolescence and young adulthood
687
Helps maintain cell health
Oral
0CE-HE-MA-HE-S00
FNFC
Helps to maintain the cell health
688
Helps in connective tissue formation
Oral
0CT-00-FO-HE-S00
HC
Helps in connective tissue formation
689
Helps to produce and repair connective
tissue
Oral
0CT-00-PD-HE-S00
HC
Helps to produce and repair connective tissue
690
Helps strengthen connective tissue
Oral
0CT-00-SN-HE-S00
BM17
Strengthen connective tissue
685
686
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 91 of 92
Therapeutic Goods Administration
Ref
No
Proposed permitted indication
691
692
Route of
admin
Target-QT-action-QAcontext
Source
Source indication
Supports energy production
Oral
0EY-00-PR-SU-S00
SAN10
Supports energy production
Helps to support a modest reduction in fat
mass when used with a program of
reduced intake of dietary calories and
increased physical activity
Oral
0FM-MR-SU-HE-S00
HC
May help to support a modest reduction in fat mass
when used with a program of reduced intake of
dietary calories and increased physical activity
693
Supports foetal growth and development
Oral
0FO-GD-SU-00-S00
SAN12
Required for foetal growth and development
694
Contributes to the normal growth of the
foetus
Oral
0FO-GR-CO-00-S00
FNFC
Contributes the normal growth of the fetus
695
Assists in the maintenance of normal
healthy blood sugar/glucose balance in
healthy individuals.
Oral
0GB-NH-MA-AS-S00
BLDGL03
May assist in the maintenance of normal healthy
blood sugar/glucose balance in healthy individuals.
Assists in the maintenance of normal
healthy glycaemic controls in healthy
individuals.
Oral
0GC-NH-MA-AS-S00
BLDGL02
May assist in the maintenance of normal healthy
glycaemic controls in healthy individuals.
697
Helps normal growth and development
Oral
0GD-NO-HE-00-S00
HC
Helps normal growth and development
698
Assists in the maintenance of normal
healthy blood sugar/glucose levels in
healthy individuals.
Oral
0GL-NH-MA-AS-S00
BLDGL01
May assist in the maintenance of normal healthy
blood sugar/glucose levels in healthy individuals.
696
Label
disclaimers
Attachment 1: Expanded list of permitted indications
Permitted (coded) indications for listed medicines - Consultation paper
January 2013
Page 92 of 92