(Form-45) Import Permission issued from January 2009 to December 2010 for Viral
Vaccines
S.No.
Name of the
Firm
Name of the
Product
Composition
Indication
Date of
Permision
1
Nirlac
Chemicals
Oral
Poliomyelitis
(Type 1)
Vaccine
Monovalent
Each 0.1 ml dose (2
drops) contains:-Live
attenuated
poliomyelitis virus
type 1(Sabin Strain)
≥106.0CCID 50,
Erythromycin ≤ 2mcg,
Kanamycin ≤10mcg,
Sucrose - 35% v/v.
Active
immunization
against
poliomyelitis
type 1
12 April, 2010
2
M/s. Kiran
Agencies
Purified rabies
vaccine (Vero
cell Freezed
dried)
For active
Immunization
angainst rabies
09th March, 2010
3
M/s. MSD
Rotavirus
Vaccine Live
Oral Pantavalent
Each Single dose 0.5
ml Vials contains
after Reconstitution
with Diluent
contains- rabies Virus
(PV 2061 strain) ≥2.5
IU
Each single dose of
2mL contains: - (API)
G1 Reassortant - 2.2
×106 IU/dose, G2
Reassortant - 2.8
×106 IU/dose, G3
Reassortant - 2.2
×106 IU/dose, G4
Reassortant - 2.0
×106 IU/dose, P1
Reassortant - 2.3
×106 IU/dose,
(Inactive Ingredient)
Sucrose – 1080mg,
Sodium citrate
Dihydrate – 127mg,
Sodium phosphate
Monobasic
Monohydrate 29.8mg, Sodium
Hydroxide - 2.75mg,
Polysorbate – 80 0.17 – 0.86mg,
Rotavirus Diluent &
LPKM-3 - 15% (v/v)
For the
prevention of
rotavirus
gastroenteritis
in infants and
children
caused by the
serotypes G1,
G2, G3 and G4
when
administered
as a 3 dose
series to
infants
between 6 to
32 weeks. The
first dose of
Rota Teq
should be
administered
between 6 and
12 weeks of
age
28th April, 2010
4
Synergy
Diagnostics
Pvt. Ltd.
rabies Vaccine
Freezed Dried
Vero Based
Each 0.5 ml
contains:- Rabies
Antigen equivalent to
≥2.5IU
For active
immunization
against Rabies,
Both as
prophylaxis
and post bite
cases
For active
immunization
against
susceptible
Influenzae
21th Oct, 2009
5
M/s. GC
Chemie
Pharma Ltd.
Influenza
Vaccine Split
Each 0.5 ml vial /PFS
contains:
A/Brisbane/59/2007
(H1N1) like virus --15mcg
,A/Brisbane/10/2007
(H3N2) like virus ---15 mcg
,B/Florida/4/2006 like
virus ------15 mcg
6
Serum
Institute of
India
Inactivated Polio
Vaccine (Type
1, 2, &3) Bulk
Inactivated Polio
Vaccine (Type 1, 2,
&3) Bulk
Active
immunization
against
poliomyelitis
(Type 1, 2, &3)
17th Feb, 2009
7
Sanofi
Pasteur India
Pvt. Ltd.,
Delhi
Influenza
Inactivated, Split
Virion, NonAdjuvanted
H1N1 vaccine.
15µg of HA/Human
dose
For active
immunization
for H1N1
pandemic
influenza
12th March, 2010
8
Ranbaxy
Laboratories
Purified rabies
vaccine (Vero
cell Freezed
dried)
Each Single
Dose(0.5ml) vial after
reconstituted with
diluents contains :
Rabies Virus (PV2061 Strain)Cultured
on Vero Cell
Inactivated) ≥2.5IU
For active
immunization
against Rabies
for Human use
only.
22th Sep, 2010
12 May, 2009