Public Assessment Report. Scientific discussion. Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets. (pantoprazole) NL/H/2751/ /DC

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1 Public Assessment Report Scientific discussion Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets (pantoprazole) NL/H/2751/ /DC Date: 27 August 2014 This module reflects the scientific discussion for the approval of Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets. The procedure was finalised on 9 March For information on changes after this date please refer to the module Update. This report includes a summary, on pages 9-11.

2 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets from Beximco Pharma UK Ltd. The 20 mg product is indicated for: Adults and adolescents 12 years of age and above Symptomatic gastro-oesophageal reflux disease. For long-term management and prevention of relapse in reflux oesophagitis. Adults Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment. The 40 mg product is indicated for: Adults and adolescents 12 years of age and above Reflux oesophagitis. Adults Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers. Gastric and duodenal ulcers. Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions. A comprehensive description of the indications and posology is given in the SmPC. This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Pantozol 40 mg and 20 mg gastro-resistant tablets (NL License RVG and 23513), which have been registered by Takeda Nederland bv since 1995 and 1998, respectively. In addition, reference is made to Pantozol authorisations (other names for the innovator product are amongst others Pantoc, Pantorc, Pantoloc, Somac) in the individual member states (reference product). The concerned member states (CMS) involved in this procedure were Czech Republic, Estonia, Latvia, Lithuania, Poland and Romania. The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction Pantoprazol Beximco 20 mg is a off-white to pale yellow colored, oval, biconvex enteric-coated tablet of about 3.3 mm, plain on both sides. The tablet contains 20 mg pantoprazole as sodium sesquihydrate. Pantoprazol Beximco 40 mg is a yellow colored, oval, biconvex enteric-coated tablet of about 4.0 mm, plain on both sides. The tablet contains 40 mg pantoprazole as sodium sesquihydrate. The tablets are packed in OPA-Al-PVC/Al blisters. The excipients are: Tablet core - mannitol (E421), sodium carbonate anhydrous, sodium starch glycolate, crospovidone type A, colloidal anhydrous silica, calcium stearate. Coating - hypromellose, macrogol-6000, sodium hydroxide, methacrylic acid-ethyl acrylate copolymer dispersion (Eudragit L30D55), for the 20 mg strength: Opadry AMB 80W and for the 40 mg strength: Opadry AMB 80W /11

3 The two strengths are fully dose proportional. II.2 Drug Substance The active substance is pantoprazole, present as pantoprazole sodium sesquihydrate, an established active substance described in the European pharmacopoeia (Ph.Eur.). The active substance is a white to off-white, crystalline powder, which is freely soluble in water and ethanol and practically insoluble in hexane. Pantoprazole sodium contains one chiral centre. The drug substance is a racemic mixture of the R and S enantiomer. The CEP procedure is used for the active substance. Under the official Certification Procedures of the EDQM of the Council of Europe, manufacturers or suppliers of substances for pharmaceutical use can apply for a certificate of suitability concerning the control of the chemical purity and microbiological quality of their substance according to the corresponding specific monograph, or the evaluation of reduction of Transmissible Spongiform Encephalopathy (TSE) risk, according to the general monograph, or both. This procedure is meant to ensure that the quality of substances is guaranteed and that these substances comply with the European Pharmacopoeia. Manufacturing process A CEP has been submitted; therefore no details on the manufacturing process have been included. Quality control of drug substance The drug substance specification is in line with the CEP, with additional requirements for residual solvents and bulk density. The specification is acceptable in view of the route of synthesis and the various European guidelines. Batch analytical data demonstrating compliance with the drug substance specification have been provided for three batches. Stability of drug substance The active substance is stable for 4 years when stored under the stated conditions. Assessment thereof was part of granting the CEP and has been granted by the EDQM. II.3 Medicinal Product Pharmaceutical development The development of the product has been described, the choice of excipients is justified and their functions explained. The dissolution method is acceptable. The biowaver for the lower tablet strength is accepted on chemical-pharmaceutical grounds. Gastro-resistance in ph range has been demonstrated. Bioequivalence studies were performed under fed and fasting state. The manufacturing process and composition of the biobatch is the same as described for commercial batches. Manufacturing process The drug product is manufactured via dry mixing process. The process involves sifting, dry mixing, lubrication, compression, seal coating. enteric coating and film coating. The manufacturing process is considered a non-standard process. Process validation data on the product has been presented for three batches of the common blend. Three tablet batches of each strength were produced using the common blend. The manufacturing process has been adequately validated. Control of excipients The excipients comply with their Ph.Eur or USP/NF monographs. These specifications are acceptable. Quality control of drug product The product specification includes tests for appearance, identification, uniformity of dosage units, average mass, related substances, gastro-resistance, disintegration, dissolution, assay and microbiological purity. The release and shelf-life limits differ only in the limits for dissolution. The analytical methods have been adequately described and validated. Batch analytical data from the proposed production site have been provided on the three full-scale batches of both strengths, demonstrating compliance with the release specification. Stability of drug product Stability data on the product has been provided for the three full-scale batches of the 20 mg tablets and three full-scale batches of the 40 mg tablets stored at 25 C/60%RH (24 months) and 40 C/75%RH (6 months). The conditions used in the stability studies are according to the ICH stability 3/11

4 guideline. The batches were stored in Al-Al blisters. The tablets were demonstrated to be photostable. Based on the results, a shelf-life of 24 months with storage condition this medicinal product does not require any special storage conditions can be granted. Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies There are no substances of ruminant animal origin present in the product nor have any been used in the manufacturing of this product, so a theoretical risk of transmitting TSE can be excluded. II.4 Discussion on chemical, pharmaceutical and biological aspects Based on the submitted dossier, the member states consider that Pantoprazol Beximco 20 mg and 40 mg have a proven chemical-pharmaceutical quality. Sufficient controls have been laid down for the active substance and finished product. The following post-approval commitments were made: The MAH committed to perform process validation on the maximal proposed commercial batches. The MAH committed to continue the formal stability studies up to 36 months. The MAH committed to perform long term stability studies (25 C ± 2 C/60%RH ± 5%RH) on the first three production-scale batches post approval. The MAH committed to evaluate the dissolution limit data of the stability batches and commercial scale batches. The MAH committed to perform Differential Scanning Calorimetry (DSC) and Infrared (IR) testing on the first three lots of the active substance that will be used for the commercial supplies. III. III.1 NON-CLINICAL ASPECTS Ecotoxicity/environmental risk assessment (ERA) Since Pantoprazol Beximco is intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. III.2 Discussion on the non-clinical aspects This product is a generic formulation of Pantozol, which is available on the European market. Reference is made to the preclinical data obtained with the innovator product. A non-clinical overview on the pharmacology, pharmacokinetics and toxicology has been provided, which is based on up-todate and adequate scientific literature. The overview justifies why there is no need to generate additional non-clinical pharmacology, pharmacokinetics and toxicology data. Therefore, the member states agreed that no further non-clinical studies are required. IV. IV.1 CLINICAL ASPECTS Introduction Pantoprazole is a well-known active substance with established efficacy and tolerability. A clinical overview has been provided, which is based on scientific literature. The overview justifies why there is no need to generate additional clinical data. Therefore, the member states agreed that no further clinical studies are required. For this generic application, the MAH has submitted two bioequivalence studies, which is discussed below. IV.2 Pharmacokinetics The MAH conducted two bioequivalence studies, one under fasting and one under fed conditions, in which the pharmacokinetic profile of the test product Pantoprazol Beximco 40 mg (Beximco Pharma UK Ltd) is compared with the pharmacokinetic profile of the reference product Pantoloc 40 mg 4/11

5 gastro-resistant tablets (Nycomed Pharma, Germany). These studies under the two conditions are adequate for this type of product. The choice of the reference product in the bioequivalence study has been justified by comparison of compositions of reference products in different member states. The formula and preparation of the bioequivalence batch is identical to the formula proposed for marketing. In both studies the analytical methods have been adequately validated and are considered acceptable for analysis of the plasma samples. The methods used in this study for the pharmacokinetic calculations and statistical evaluation are considered acceptable. Biowaiver A biowaiver has been granted for the 20 mg strength, as the following conditions have been fulfilled: - the two different strengths are manufactured by same manufacturing process. - pantoprazole gastro-resistant tablets 20mg are developed as dose proportional formula (scale down). The ratio between amounts of excipients is similar. - the qualitative composition of pantorazole gastro-resistant tablets 20mg and 40mg is the same. - pantoprazole shows linear pharmacokinetics. - The dissolution profile of pantoprazole gastro-resistant tablets 40 mg is comparable to the 20 mg gastro-resistant tablets, using dissolution testing in ph 6.8 after 2 hours in 0.1N HCl medium and using dissolution in ph 4.5 after 2 h in 0.1N HCl. Bioequivalence studies Study I fasting conditions Design A single-dose, randomised, two-period, two-treatment, two-sequence, crossover bioequivalence study was carried out under fasting conditions in 32 healthy subjects (29 males, 3 females), aged years. Each subject received a single dose (40 mg) of one of the 2 pantoprazole formulations. The tablet was orally administered with 240 ml water under fasting conditions. There were 2 dosing periods, separated by a washout period of 11 days. Blood samples were collected pre-dose and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after administration of the products. This single-dose, crossover study to assess bioequivalence is considered adequate. Results One subject was withdrawn due to a positive urine test for drug abuse. The other subjects completed the study. Pharmacokinetic and statistical analysis were carried out on 31 subjects. Table 1. Pharmacokinetic parameters (non-transformed values; arithmetic mean ± SD, t max (median, range)) of pantoprazole under fasting conditions. Treatment AUC 0-t AUC 0- C max t max t 1/2 N=31 ng.h/ml ng.h/ml ng/ml h h Test Reference *Ratio (90% CI) 0.96 ( ) ( ) CV (%) AUC 0- area under the plasma concentration-time curve from time zero to infinity AUC 0-t area under the plasma concentration-time curve from time zero to t hours C max maximum plasma concentration t max time for maximum concentration t 1/2 half-life *ln-transformed values 5/11

6 Study II fed conditions Design A single-dose, randomised, two-period, two-treatment, two-sequence, crossover bioequivalence study was carried out under fed conditions in 52 healthy subjects (49 males, 3 females), aged years. The tablet was administered after intake of a high fat, high caloric breakfast ( cal; 29.1% from carbohydrates, 13.5% from protein and 57.4% from fat). The formulations were administered in solid form with 240 ml water. There were 2 dosing periods, separated by a washout period of 7 days. Blood samples were collected pre-dose and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after administration of the products. This single-dose, crossover design is considered adequate. Results All subjects completed the study. Pharmacokinetic and statistical analysis were carried out on 52 subjects. Table 2. Pharmacokinetic parameters (non-transformed values; arithmetic mean ± SD, t max (median, range)) of pantoprazole under fed conditions. Treatment AUC 0-t AUC 0- C max t max t 1/2 N=52 ng.h/ml ng.h/ml ng/ml h h Test Reference *Ratio (90% CI) 0.96 ( ) ( ) CV (%) AUC 0- area under the plasma concentration-time curve from time zero to infinity AUC 0-t area under the plasma concentration-time curve from time zero to t hours C max maximum plasma concentration t max time for maximum concentration t 1/2 half-life *ln-transformed values Conclusion on bioequivalence studies The 90% confidence intervals calculated for AUC 0-t, AUC 0- and C max are within the bioequivalence acceptance range of Based on the submitted bioequivalence studies Pantoprazol Beximco 40 mg is considered bioequivalent with Pantoloc 40 mg gastro-resistant tablets, under both fasting and fed conditions. The MEB has been assured that the bioequivalence studies have been conducted in accordance with acceptable standards of Good Clinical Practice (GCP, see Directive 2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and 2004/10/EC). IV.3 Risk Management Plan The MAH has submitted a risk management plan, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Pantoprazol Beximco gastro-resistant tablets. Summary table of safety concerns as approved in RMP Important identified risks Hypersensitivity to pantoprazole or other substituted benzimidazoles Malabsorption of vitamin B12 Chronic treatment with PPIs and hypomagnesaemia Increased risk of fractures of the hip, wrist, and spine with the long 6/11

7 term use of PPIs Visual disturbances Important potential risks Masking of gastro-intestinal malignancies Reduced effect of co-administered drugs that depend on gastric ph for absorption, especially atazanavir Increased risk of gastro-intestinal infection; particularly Clostridium difficile associated diarrhoea Off-label use Increased risk of pneumonia Congenital cardiac malformation following in utero exposure. Interactions with Warfarin or other coumarin derivatives, Atazanavir, Nelfinavir, Digoxin, methotrexate, tacrolimus. Important missing Use in patients with severe hepatic impairment information Use in patients with renal impairment Use in pregnancy, lactation and children below the age of 12 years. The member states agree that no additional pharmacovigilance activities beyond routine pharmacovigilance measures are required. IV.4 Discussion on the clinical aspects For this authorisation, reference is made to the clinical studies and experience with the innovator product Pantozol gastro-resistant tablets. No new clinical studies were conducted. The MAH demonstrated through a bioequivalence study that the pharmacokinetic profile of the product is similar to the pharmacokinetic profile of this reference product. Risk management is adequately addressed. This generic medicinal product can be used instead of the reference product. V. USER CONSULTATION The package leaflet has been evaluated via a user consultation study in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The study design, key massages, questionnaire and results from the preliminary and the two rounds of testing as well as the results from the general questions, indicates no particular issues with regard to the content and layout of the leaflet. The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets have a proven chemicalpharmaceutical quality and are generic forms of Pantozol gastro-resistant tablets. Pantozol is a wellknown medicinal product with an established favourable efficacy and safety profile Bioequivalence has been shown to be in compliance with the requirements of European guidance documents, under fasting and fed conditions. The Board followed the advice of the assessors. There was no discussion in the CMD(h). Agreement between member states was reached during a written procedure. The member states, on the basis of the data submitted, considered that essential similarity has been demonstrated for Pantoprazol Beximco with the reference product, and have therefore granted a marketing authorisation. The decentralised procedure was finalised with a positive outcome on 9 March /11

8 STEPS TAKEN AFTER THE FINALISATION OF THE INITIAL PROCEDURE - SUMMARY Scope Procedure number Type of modification Date of start of the procedure Date of end of the procedure Approval/ non approval Assessment report attached 8/11

9 Summary Public Assessment Report Generics Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets pantoprazole NL/H/2751/ /DC Date: 27 August /11

10 Summary Public Assessment Report Generics Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets Active substance: pantoprazole This is a summary of the public assessment report (PAR) for Pantoprazol Beximco gastro-resistant tablets. It explains how this medicine was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Pantoprazol Beximco. For practical information about using this medicine, patients should read the package leaflet or contact their doctor or pharmacist. What is Pantoprazol Beximco and what is it used for? Pantoprazol Beximco is a generic medicine. This means that it is similar to a reference medicine already authorised in the European Union (EU) called Pantozol gastro-resistant tablets. This medicine is prescribed for treatment of acid-related disease of the stomach and intestine. This includes: symptoms such as heartburn, acid reflux, pain on swallowing, caused by reflux of acid (rising up of stomach acid into the esophagus) from the stomach in case of oesophageal disease (long-term) management of reflux oesophagits (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return. Prevention or treatment of duodenal and stomach ulcers caused by non-steroidal antiinflammatory drugs (NSAIDs for example, ibuprofen) in patients at risk who need to take NSAIDs continuously. Treatment of an infection with a bacterium called Helicobacter pylori in patients with H. pylori associated ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning. Zollinger-Ellison-Syndrome and other pathological conditions producing too much acid in the stomach. Read the package leaflet for further details. The right dose, 20 mg or 40 mg, depends on the condition. This medicine should not be used by children below 12 years of age. For certain symptoms this medicine can be used from the age of 12. However, for some types of disease this medicine is only indicated in adults. Refer to the package leaflet and always follow the advice of the prescribing doctor. How is this medicine used? The medicine can only be obtained with a prescription. The tablets should be taken with some water 1 hour before a meal. They should be swallowed whole without chewing and breaking. The usual dose is one tablet a day. The duration of treatment depends on the patient s condition and the time it takes to recover. Further information can be found in the package leaflet. How does this medicine work? The active substance pantoprazole is a selective proton pump inhibitor, a medicine which reduces the amount of acid produced in the stomach. Herewith it relieves the symptoms of acid reflux. The tablets are gastro-resistant. This means that the tablet passes through the stomach without being broken down until it reaches the intestine. This prevents the active substance being destroyed by the acid in the stomach. How has this medicine been studied? Because Pantoprazol Beximco is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Pantozol gastro-resistant tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. 10/11

11 What are the benefits and risks of this medicine? Because Pantoprazol Beximco is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine, Pantozol. Why is this medicine approved? It was concluded that, in accordance with EU requirements, this medicine has been shown to have comparable quality and to be bioequivalent to the reference medicine. Therefore, the view was that, as for Pantozol, the benefit outweighs the identified risk. What measures are being taken to ensure the safe and effective use of this medicine? A risk management plan has been developed to ensure that this medicine is 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 Pantoprazol Beximco, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about this medicine In the Netherlands, the marketing authorisation for Pantoprazol Beximco 20 mg and 40 mg, gastroresistant tablets was granted on 2 June The full PAR for this medicine can be found on the website For more information about treatment with Pantoprazol Beximco, read the package leaflet ( for the 20 mg strength and for the 40 mg strength or contact your doctor or pharmacist. This summary was last updated in August /11

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