Public Assessment Report
Decentralised Procedure
LANSOPRAZOLE 15 MG AND 30 MG ORODISPERSIBLE
TABLETS
(lansoprazole)
Procedure No: UK/H/3509/01-02/DC
UK Licence No: PL 35507/0118-0119
Lupin (Europe) Limited
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
LAY SUMMARY
Lansoprazole 15 mg and 30 mg Orodispersible Tablets
(Lansoprazole)
This is a summary of the public assessment report (PAR) for Lansoprazole 15 mg and 30 mg
Orodispersible Tablets (PL 35507/0118-0119). It explains how Lansoprazole 15 mg and 30 mg
Orodispersible Tablets were assessed and their authorisation recommended as well as their conditions of
use. It is not intended to provide practical advice on how to use Lansoprazole 15 mg and 30 mg
Orodispersible Tablets.
For practical information about using Lansoprazole 15 mg and 30 mg Orodispersible Tablets, patients
should read the package leaflet or contact their doctor or pharmacist.
What are Lansoprazole 15 mg and 30 mg Orodispersible Tablets and what are they used for?
Lansoprazole 15 mg and 30 mg Orodispersible Tablets are generic medicines. This means that
Lansoprazole 15 mg and 30 mg Orodispersible Tablets are similar to ‘reference medicines’ already
authorised in the European Union (EU) called Zoton FasTab*15 mg and 30 mg Oro-dispersible Tablets
(Pfizer Limited; PL 00057/1296-1297).
Lansoprazole 15 mg and 30 mg Orodispersible Tablets are used for treating acid-related conditions of
the stomach and gastrointestinal tract, infections caused by the bacteria Helicobacter pylori and also in
the treatment of Zollinger-Ellison syndrome.
How are Lansoprazole 15 mg and 30 mg Orodispersible Tablets used?
Lansoprazole 15 mg and 30 mg Orodispersible Tablets are taken by mouth. The tablet should be placed
on the tongue and sucked gently. It will then rapidly dissolve in the mouth, releasing pellets which
should be swallowed without chewing. The whole tablet can also alternatively be swallowed with a glass
of water. These medicines can only be obtained on prescription from the doctor.
The dosage of the tablets depends on the condition being treated. Details of the correct dose to be given
are included in the package leaflet.
How do Lansoprazole 15 mg and 30 mg Orodispersible Tablets work?
Lansoprazole 15 mg and 30 mg Orodispersible Tablets belong to a group of medicines called “proton
pump inhibitors”. They work by reducing the amount of acid produced in the stomach.
How have Lansoprazole 15 mg and 30 mg Orodispersible Tablets been studied?
Because Lansoprazole 15 mg and 30 mg Orodispersible Tablets are generic medicines, studies in
patients have been limited to tests to determine that they are bioequivalent to the reference medicines,
Zoton FasTab* 15 mg and 30 mg Oro-dispersible Tablets (Pfizer Limited; PL 00057/1296-1297). Two
medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks of Lansoprazole 15 mg and 30 mg Orodispersible Tablets?
As Lansoprazole 15 mg and 30 mg Orodispersible Tablets are generic medicines that are bioequivalent
to Zoton FasTab* 15 mg and 30 mg Oro-dispersible Tablets (Pfizer Limited), their benefits and risks are
taken as being the same as those of Zoton FasTab* 15 mg and 30 mg Oro-dispersible Tablets (Pfizer
Limited).
Why are Lansoprazole 15 mg and 30 mg Orodispersible Tablets approved?
It was concluded that, in accordance with EU requirements, Lansoprazole 15 mg and 30 mg
Orodispersible Tablets have been shown to have comparable quality and to be bioequivalent to Zoton
FasTab* 15 mg and 30 mg Oro-dispersible Tablets. Therefore, the view was that, as for Zoton FasTab*
15 mg and 30 mg Oro-dispersible Tablets the benefit outweighs the identified risk.
2
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
What measures are being taken to ensure the safe and effective use of Lansoprazole 15 mg and 30
mg Orodispersible Tablets?
A risk management plan has been developed to ensure that Lansoprazole 15 mg and 30 mg
Orodispersible Tablets are used as safely as possible. Based on this plan, safety information has been
included in the Summary of Product Characteristics and the package leaflet for Lansoprazole 15 mg and
30 mg Orodispersible Tablets, including the appropriate precautions to be followed by healthcare
professionals and patients.
Other information about Lansoprazole 15 mg and 30 mg Orodispersible Tablets
Italy, Republic of Ireland, Spain and the UK agreed to grant Marketing Authorisations for Lansoprazole
15 mg and 30 mg Orodispersible Tablets on 29th December 2013. Marketing Authorisations were
granted in the UK on 23rd January 2014.
The full PAR for Lansoprazole 15 mg and 30 mg Orodispersible Tablets follows this summary. For
more information about treatment with Lansoprazole 15 mg and 30 mg Orodispersible Tablets, read the
package leaflet or contact your doctor or pharmacist.
This summary was last updated in March 2014.
3
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
TABLE OF CONTENTS
Module 1: Information about initial procedure
Page 5
Module 2: Summary of Product Characteristics
Page 6
Module 3: Patient Information Leaflet
Page 7
Module 4: Labelling
Page 8
Module 5: Scientific discussion during initial procedure
Page 12
I
II
III
III.1
III.2
III.3
IV
Introduction
About the product
Scientific overview and discussion
Quality aspects
Non-clinical aspects
Clinical aspects
Overall conclusion and benefit-risk assessment
Module 6: Steps taken after initial procedure
Page 20
4
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Module 1
Information about initial procedure
Product Name
Lansoprazole 15 mg and 30 mg Orodispersible Tablets
Type of Application
Generic, Article 10(1)
Active Substances
Lansoprazole
Form
Orodispersible Tablets
Strength
15 mg and 30 mg
MA Holder
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
WA16 0PF
United Kingdom
Reference Member State (RMS)
UK
Concerned Member States (CMSs)
Italy, Republic of Ireland and Spain
Procedure Numbers
UK/H/3509/01-02/DC
Timetable
Day 210 – 29th December 2013
5
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Module 2
Summary of Product Characteristics
In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) for
products that have been granted Marketing Authorisations at a national level are available on the MHRA
website.
6
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Module 3
Patient Information Leaflet
In accordance with Directive 2010/84/EU the Patient Information Leaflets for products that are granted
Marketing Authorisations at a national level are available on the MHRA website.
7
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Module 4
Labelling
8
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
9
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
10
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
11
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Module 5
Scientific discussion during initial procedure
I
INTRODUCTION
Based on the review of the data on quality, safety and efficacy, the Member States considered that the
applications for Lansoprazole 15 mg and 30 mg Orodispersible Tablets (PL 35507/0118-0119;
UK/H/3509/01-02/DC) could be approved. These products are prescription-only medicines (POM) used
for the following indications:
• Treatment of duodenal and gastric ulcer
• Treatment of reflux oesophagitis
• Prophylaxis of reflux oesophagitis
• Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy
for treatment of H.pylori-associated ulcers
• Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued
NSAID treatment
• Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk requiring
continued therapy
• Symptomatic gastroesophageal reflux disease
• Zollinger-Ellison syndrome.
Lansoprazole orodispersible tablets are indicated in adults.
These applications were made under the Decentralised Procedure (DCP) according to Article 10(1) of
Directive 2001/83/EC, as amended. The applicant has cross referred to Zoton FasTab* 15 mg and 30 mg
Oro-dispersible Tablets, originally granted to Cyanamid of Great Britain Limited (PL 00095/0322-0323)
on 24th August 2001. These reference licences underwent Change of Ownership procedures to John
Wyeth & Brother Limited (PL 00011/0289-0290) on 26th January 2004 and then to the current
Marketing Authorisation holder, Pfizer Limited (PL 00057/1296-1297), on 17th June 2011.
With the UK as the RMS in these Decentralised Procedures, Lupin (Europe) Limited applied for
Marketing Authorisations for Lansoprazole 15 mg and 30 mg Orodispersible Tablets in Italy, Republic
of Ireland and Spain.
Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by
inhibiting the activity of H+/K+ ATPase of the parietal cells in the stomach. The inhibition is dosedependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.
Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment,
whereupon it reacts with the sulphydryl group of H+/K+ATPase causing inhibition of the enzyme
activity.
With the exception of the bioequivalence studies, no new non-clinical or clinical studies were
conducted, which is acceptable given that the applications were based on being generic medicinal
products of originator products that have been licensed for over 10 years.
Two bioequivalence studies were submitted to support these applications, comparing the applicant’s test
product Lansoprazole 30 mg Orodispersible Tablets (Lupin Limited) with the reference product Ogast
ORO® (Lansoprazole) 30 mg Orodispersible Tablets (Laboratories TAKEDA 11-15) in healthy adult
male subjects, under fasting and fed conditions. The applicant has confirmed that the reference product
used for the bioequivalence study is under the same global Marketing Authorisation as the UK reference
product. Bioequivalence studies were carried out in accordance with Good Clinical Practice (GCP).
12
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
The RMS has been assured that acceptable standards of Good Manufacturing Practice are in place for
this product type at all sites responsible for the manufacture, assembly and batch release of these
products.
For manufacturing sites outside the community, the RMS has accepted copies of current GMP
Certificates or satisfactory inspection summary reports, ‘close-out letters’ or ‘exchange of information’
issued by the inspection services of the competent authorities (or those countries with which the EEA
has a Mutual Recognition Agreement for their own territories) as certification that acceptable standards
of GMP are in place at those non-Community sites.
All involved Member States agreed to grant Marketing Authorisations for the above products at the end
of the procedure (Day 210 – 29th December 2013). After a subsequent national phase, the UK granted
Marketing Authorisations for these products on 23rd January 2014 (PL 35507/0118-0119).
13
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
II.
UK/H/3509/01-02/DC
ABOUT THE PRODUCT
Name of the product in the Reference Member
State
Name(s) of the active substance(s) (INN)
Pharmacotherapeutic classification
(ATC code)
Pharmaceutical form and strength(s)
Reference numbers for the Decentralised
Procedure
Reference Member State
Concerned Member States
Marketing Authorisation Number(s)
Name and address of the authorisation holder
Lansoprazole 15 mg and 30 mg Orodispersible
Tablets
Lansoprazole
Proton pump inhibitors
(A02BC03)
Orodispersible Tablets, 15 mg and 30 mg
UK/H/3509/01-02/DC
UK
Italy, Republic of Ireland and Spain
PL 35507/0118-0119
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
WA16 0PF
United Kingdom
14
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
III
SCIENTIFIC OVERVIEW AND DISCUSSION
III.1 QUALITY ASPECTS
DRUG SUBSTANCE
INN:
Chemical name(s):
Lansoprazole
2-[[[3-methyl-4-(2, 2, 2-trifluoroethyxy)-2-pyridinyl]methyl]sulfonyl]-1Hbenzimidazole
Structure:
Molecular formula:
Molecular weight:
Appearance:
Solubility:
C16H14F3N3O2S
369.4 g/mol
White or brownish powder
Freely soluble in dimethylformamide, soluble in methanol, very slightly soluble in
acetonitrile, practically insoluble in water
Lansoprazole is the subject of an active substance master file (ASMF).
Synthesis of the drug substance from the designated starting materials has been adequately described
and appropriate in-process controls and intermediate specifications are applied. Satisfactory
specification tests are in place for all starting materials and reagents, and these are supported by relevant
Certificates of Analysis.
An appropriate specification is provided for the drug substance. Analytical methods have been
appropriately validated and are satisfactory for ensuring compliance with the relevant specifications.
Certificates of Analysis for all working standards have been provided.
Batch analysis data are provided that comply with the proposed specification.
Satisfactory specifications and Certificates of Analysis have been provided for all packaging used to
store the drug substance. Confirmation has been provided that the primary packaging complies with
current guidelines concerning materials in contact with food.
Appropriate stability data have been generated, supporting a suitable retest period when the drug
substance is stored in the packaging proposed.
DRUG PRODUCT
Other Ingredients
Other ingredients consist of the pharmaceutical excipients, as follows:
Tablet core: microcrystalline cellulose, light magnesium carbonate, low-substituted hydroxypropyl
cellulose and hydroxypropyl cellulose (E463)
Barrier coating: hypromellose 3 cps (E464), low substituted hydroxypropyl cellulose, talc (E553b),
titanium dioxide (E171) and mannitol (E421)
15
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Enteric coating: methacrylic acid ethyl acrylate copolymer dispersion (1:1), polyacrylate dispersion,
glycerol monostearate, polyethylene glycol 6000, polysorbate 80 (Crillet 4), triethyl citrate, polysorbate
80, anhydrous citric acid (E330), yellow ferric oxide (E172), red ferric oxide (E172) and talc (E553b).
Compressed tablet: F-Melt Type C (which contains: mannitol, xylitol, microcrystalline cellulose,
crospovidone, anhydrous dibasic calcium phosphate), crospovidone, microcrystalline cellulose,
aspartame (E951), strawberry flavour (which contains: flavouring, maize maltodextrin, propylene
glycol) and magnesium stearate (vegetable grade) (E470b).
All excipients used comply with their respective European Pharmacopoeia monographs.
None of the excipients are sourced from animal or human origin. No genetically modified organisms
(GMO) have been used in the preparation of these products.
Pharmaceutical Development
The objective of the development programme was to formulate robust, stable orodispersible tablets
containing the same active ingredient as Zoton FasTab* 15 mg and 30 mg Oro-dispersible Tablets
(Pfizer Limited).
Comparative dissolution and impurity profiles have been presented for the proposed and reference
products.
Manufacturing Process
Satisfactory batch formulae have been provided for the manufacture of the products, along with an
appropriate account of the manufacturing processes. The manufacturing processes have been validated
using the minimum commercial scale batch sizes and have shown satisfactory results. The applicant has
committed to perform validation on the first three full scale commercial-scale batches post approval.
Finished Product Specification
The finished product specifications are satisfactory. Test methods have been described and adequately
validated. Batch data have been provided that comply with the release specification. Certificates of
Analysis have been provided for any working standards used.
Container-Closure System
The finished products are packaged in an aluminium/aluminium blister with aluminium lidding foil or a
cold form desiccant blister with aluminium lidding foil, in a carton with pack sizes of 7, 14, 28, 56, and
98 tablets.
Satisfactory specifications and Certificates of Analysis have been provided for all packaging
components. All primary packaging complies with the current European regulations concerning
materials in contact with food.
Stability
Finished product stability studies have been conducted in accordance with current guidelines and in the
packaging proposed for marketing.
Based on the results a shelf-life of 2 years with storage conditions “Store below 25°C” and “Store in the
original package in order to protect from moisture” have been set. These are satisfactory.
Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels
The SmPCs, PIL and labels are acceptable from a pharmaceutical perspective.
A package leaflet has been submitted to the MHRA together with results of consultations with target
16
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC, as
amended. The results indicate that the package leaflet is well-structured and organised, easy to
understand and written in a comprehensive manner. The test shows that the patients/users are able to act
upon the information that the package leaflet contains.
Marketing Authorisation Application (MAA) forms
The MAA forms are satisfactory from a pharmaceutical perspective.
Expert report/Quality Overall Summary
The quality overall summary has been written by an appropriately qualified person and is a suitable
summary of the pharmaceutical aspects of the dossier.
Conclusion
There are no objections to the approval of these products from a pharmaceutical point of view.
III.2 NON-CLINICAL ASPECTS
The pharmacodynamic, pharmacokinetic and toxicological properties of lansoprazole are well known.
No new non-clinical data have been supplied with these applications and none are required for
applications of this type. The non-clinical overview has been written by an appropriately qualified
person and is a suitable summary of the non-clinical aspects of the dossier.
A suitable justification has been provided for not submitting an environmental risk assessment. As these
products are intended for generic substitution with products that are currently marketed, no increase in
environmental burden is expected.
There are no objections to the approval of these products from a non-clinical point of view.
III.3 CLINICAL ASPECTS
Pharmacokinetics
In support of these applications, the Marketing Authorisation Holder has submitted two bioequivalence
studies, fasting and fed, with the 30 mg formulation:
Study 1: Single dose 30 mg Tablet Bioequivalence Study under Fasting Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, crossover, balanced,
single dose bioequivalence study comparing the pharmacokinetics of the test product
Lansoprazole 30 mg Orodispersible Tablets (Lupin Limited) with the reference product OGAST
ORO® (Lansoprazole) 30 mg Orodispersible Tablets (Laboratories TAKEDA 11-15) in healthy
adult male subjects, under fasting conditions.
Blood samples were collected at pre-dose and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00,
8.00, 10.00, 12.00 and 24.00 hours post dose. The washout period was 7 days.
Geometric Least Square Mean, Ratios and 90% Confidence Interval for Lansoprazole (n=49)
PK Parameter
Geometric Least Square Mean
90% Confidence
Test (T)
Reference (R) Ratio (T/R)% Interval
Cmax (ng/ml)
1212.99
1292.96
93.82
88.41 – 99.55%
AUC0-t (ng*h/ml)
4257.57
4342.20
98.05
94.05 – 102.22%
The 90% confidence intervals for Cmax and AUC0-t were within the pre-defined limits acceptance criteria
specified in “Guideline on the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 Rev 1/
Corr**). Bioequivalence has been shown for the test formulation (Lansoprazole 30 mg Orodispersible
17
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Tablets) and the reference formulation (OGAST ORO® (Lansoprazole) 30 mg Orodispersible Tablets)
under fasting conditions.
Study 2: Single dose 30 mg Tablet Bioequivalence Study under Fed Conditions
This is an open label, randomized, two-period, two-treatment, two-sequence, crossover, balanced,
single dose oral bioequivalence study comparing the pharmacokinetics of the test product
Lansoprazole Orodispersible Tablets 30 mg (Lupin Limited) with the reference product ‘OGAST
ORO® (Lansoprazole) Orodispersible Tablets 30 mg (Laboratories TAKEDA 11-15) in healthy
adult male subjects, under fed conditions.
Blood samples were collected at pre-dose and at 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00,
9.00, 10.00, 12.00, 16.00 and 24.00 hours post dose. There was a washout period of 7 days between
study drug administrations.
Geometric Least Square Mean, Ratios and 90% Confidence Interval for Lansoprazole (n=40)
PK Parameter
Geometric Least Square Mean
90% Confidence
Interval
Test (T)
Reference (R) Ratio (T/R)%
Cmax (ng/ml)
561.65
613.71
91.52
81.32 – 102.99%
AUC0-t (ng*h/ml)
2346.49
2427.77
96.65
86.33 – 108.21%
The 90% confidence intervals for Cmax and AUC0-t were within the pre-defined limits acceptance criteria
specified in “Guideline on the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 Rev 1/
Corr**). Bioequivalence has been shown for the test formulation (Lansoprazole 30 mg Orodispersible
Tablets) and the reference formulation (OGAST ORO® (Lansoprazole) 30 mg Orodispersible Tablets)
under fed conditions.
Satisfactory justification is provided for a bio-waiver for the applicant’s lower strength tablets. As
Lansoprazole 15 mg and 30 mg Orodispersible Tablets meet the criteria specified in the “Guideline on
the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 Rev 1/ Corr**), the results and
conclusions of the bioequivalence study for 30 mg formulation can be extrapolated to the other strength,
i.e. 15 mg Orodispersible Tablets.
Efficacy
No new data on efficacy have been submitted and none are required for this type of application.
Safety
No new safety data were submitted and none are required.
Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labelling
The SmPCs, PIL and labelling are medically satisfactory and consistent with those for the reference
products.
Pharmacovigilance System and Risk Management Plan
The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides
adequate evidence that the applicant has access to the services of a qualified person responsible for
pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected
of occurring either in the Community or in a third country.
A suitable risk management plan has been provided for these products.
Clinical Expert Report
The clinical expert report has been written by an appropriately qualified physician and is a suitable
18
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
summary of the clinical aspects of the dossier.
Conclusion
The grant of Marketing Authorisations is recommended.
IV
OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT
QUALITY
The important quality characteristics of Lansoprazole 15 mg and 30 mg Orodispersible Tablets are
well-defined and controlled. The specifications and batch analytical results indicate consistency from
batch to batch. There are no outstanding quality issues that would have a negative impact on the
benefit-risk balance.
NON-CLINICAL
No new non-clinical data were submitted and none are required for applications of this type.
CLINICAL
Bioequivalence has been demonstrated between the applicant’s Lansoprazole 30 mg Orodispersible
Tablets and the reference product, OGAST ORO® (Lansoprazole) 30 mg Orodispersible Tablets after
single dose under fasting and fed conditions.
Satisfactory justification is provided for a bio-waiver for the applicant’s lower strength tablets. As
Lansoprazole 15 mg and 30 mg Orodispersible Tablets meet the criteria specified in the “Guideline on
the Investigation of Bioequivalence” (CPMP/EWP/QWP/1401/98 Rev 1/ Corr**), the results and
conclusions of the bioequivalence study for 30 mg formulation can be extrapolated to the other strength,
i.e. 15 mg Orodispersible Tablets.
No new or unexpected safety concerns arose from these applications.
The SmPCs, PIL and labelling are satisfactory and consistent with those for the reference products.
BENEFIT-RISK ASSESSMENT
The quality of the product is acceptable, and no new non-clinical or clinical concerns have been
identified. Bioequivalence has been demonstrated between the applicant’s product and the reference
product. Extensive clinical experience with lansoprazole is considered to have demonstrated the
therapeutic value of the compound. The benefit-risk assessment is, therefore, considered to be positive.
19
PAR Lansopr azole 15 mg and 30 mg Or odisper sible Tablets
UK/H/3509/01-02/DC
Module 6
STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY
Date
submitted
Application
type
Scope
Outcome
20