Public Assessment Report. Decentralised Procedure

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1 Public Assessment Report Decentralised Procedure LANSOPRAZOLE 15 MG AND 30 MG ORODISPERSIBLE TABLETS (lansoprazole) Procedure No: UK Licence No: PL 35507/ Lupin (Europe) Limited

2 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/ ). 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/ ). 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/ ). 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

3 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 29 th December Marketing Authorisations were granted in the UK on 23 rd January 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

4 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

5 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 Form Strength MA Holder Reference Member State (RMS) Concerned Member States (CMSs) Procedure Numbers Lansoprazole Orodispersible Tablets 15 mg and 30 mg Lupin (Europe) Limited Victoria Court Bexton Road Knutsford Cheshire WA16 0PF United Kingdom UK Italy, Republic of Ireland and Spain Timetable Day th December

6 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

7 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

8 Module 4 Labelling 8

9 9

10 10

11 11

12 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/ ; ) 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/ ) on 24 th August These reference licences underwent Change of Ownership procedures to John Wyeth & Brother Limited (PL 00011/ ) on 26 th January 2004 and then to the current Marketing Authorisation holder, Pfizer Limited (PL 00057/ ), on 17 th June 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

13 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 th December 2013). After a subsequent national phase, the UK granted Marketing Authorisations for these products on 23 rd January 2014 (PL 35507/ ). 13

14 II. ABOUT THE PRODUCT Name of the product in the Reference Member Lansoprazole 15 mg and 30 mg Orodispersible State Tablets Name(s) of the active substance(s) (INN) Lansoprazole Pharmacotherapeutic classification Proton pump inhibitors (ATC code) (A02BC03) Pharmaceutical form and strength(s) Orodispersible Tablets, 15 mg and 30 mg Reference numbers for the Decentralised Procedure Reference Member State UK Concerned Member States Italy, Republic of Ireland and Spain Marketing Authorisation Number(s) PL 35507/ Name and address of the authorisation holder Lupin (Europe) Limited Victoria Court Bexton Road Knutsford Cheshire WA16 0PF United Kingdom 14

15 III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS DRUG SUBSTANCE INN: Chemical name(s): Structure: Lansoprazole 2-[[[3-methyl-4-(2, 2, 2-trifluoroethyxy)-2-pyridinyl]methyl]sulfonyl]-1Hbenzimidazole Molecular formula: Molecular weight: Appearance: Solubility: C 16 H 14 F 3 N 3 O 2 S 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

16 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

17 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, and 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 C max (ng/ml) % AUC 0-t (ng*h/ml) % The 90% confidence intervals for C max and AUC 0-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

18 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, and 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 Test (T) Reference (R) Ratio (T/R)% Interval C max (ng/ml) % AUC 0-t (ng*h/ml) % The 90% confidence intervals for C max and AUC 0-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

19 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

20 Module 6 STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 20

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