Public Assessment Report. Decentralised Procedure

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1 Public Assessment Report Decentralised Procedure Levetiracetam 250 mg film-coated tablets PL 36390/0168; UK/H/5630/001/DC Levetiracetam 500 mg film-coated tablets PL 36390/0169; UK/H/5630/002/DC Levetiracetam 750 mg film-coated tablets PL 36390/0170; UK/H/5630/003/DC Levetiracetam 1000 mg film-coated tablets PL 36390/0171; UK/H/5630/004/DC Levetiracetam Cipla (EU) Limited

2 LAY SUMMARY This is a summary of the Public Assessment Report (PAR) for Levetiracetam 250, 500, 750 & 1000mg film-coated tablets (PL 36390/ ; ). Levetiracetam 250, 500, 750 & 1000mg film-coated tablets will be termed Levetiracetam film-coated tablets throughout this PAR for ease of reading. It explains how Levetiracetam film-coated tablets were assessed and their authorisations recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use these products. For practical information about using Levetiracetam film-coated tablets, patients should read the Package Leaflet or contact their doctor or pharmacist. What are Levetiracetam film-coated tablets and what are they used for? Levetiracetam film-coated tablets are a generic medicine. This means that they are similar to a reference medicine, already authorised in the European Union (EU) called Keppra film-coated tablets. Levetiracetam film-coated tablets are treatments for epilepsy. They are to be used: on their own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation. as an add-on to other antiepileptic drugs to treat o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age o myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy o primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy How do Levetiracetam film-coated tablets work? Levetiracetam film-coated tablets contain the active substance levetiracetam. This is an antiepileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way that levetiracetam works is still unclear, but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells. This helps levetiracetam to stabilise electrical activity in the brain and prevent seizures. Each film-coated tablet contains 250, 500, 750 or 1000mg levetiracetam. How are Levetiracetam film-coated tablets used? Levetiracetam film-coated tablets should be taken twice a day, once in the morning and once in the evening, at about the same time each day. They should be taken as per the doctor s instructions. The tablets should be swallowed with a sufficient quantity of liquid (e.g. a glass of water). Please read Section 3 of the Package Leaflet for detailed information on dosing recommendations, the route of administration and the duration of treatment. This medicine can only be obtained with a prescription. How have Levetiracetam film-coated tablets been studied? Because Levetiracetam film-coated tablets are generic medicines, studies in patients have been limited to tests to determine that they are bioequivalent to the reference medicine, 2

3 Keppra film coated tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the possible side effects of Levetiracetam film-coated tablets? Because Levetiracetam film-coated tablets are a generic medicine, their benefits and possible side-effects are taken as being the same as the reference medicine, Keppra film-coated tablets. For further information, please see Section 4 the Package Leaflet. Why are Levetiracetam film-coated tablets approved? It was concluded that, in accordance with EU requirements, Levetiracetam film-coated tablets have been shown to have comparable quality and be bioequivalent to Keppra film-coated tablets. Therefore, the view was that, as for Keppra film-coated tablets, the benefits outweigh the identified risks and it was recommended that Levetiracetam film-coated tablets can be approved for use. What measures are being taken to ensure the safe and effective use of Levetiracetam film-coated tablets? A risk management plan (RMP) has been developed to ensure that Levetiracetam film-coated 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 Levetiracetam film-coated tablets 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 and healthcare professionals will be monitored and reviewed continuously as well. Other information about Levetiracetam film-coated tablets Bulgaria, Cyprus, Czech Republic, Denmark, Greece, France, Croatia, Hungary, Ireland, Italy, Malta, Norway, Romania, Sweden, Slovenia, Slovak Republic and the UK agreed to grant marketing authorisations for Levetiracetam film-coated tablets on 02 December The marketing authorisations in the UK were granted on 19 January The full PAR for Levetiracetam film-coated tablets follows this summary. For more information about treatment with Levetiracetam film-coated tablets, read the Package Leaflet or contact your doctor or pharmacist. This summary was last updated in March

4 TABLE OF CONTENTS I Introduction Page 5 II Quality aspects Page 7 III Non-clinical aspects Page 8 IV Clinical aspects Page 9 V User consultation Page 13 VI Overall conclusion, benefit/risk assessment and recommendation Page 13 Table of content of the PAR update for MRP and DCP Page 17 4

5 I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Reference Member State (RMS) and Concerned Member States (CMSs) considered that the applications for Levetiracetam 250, 500, 750 & 1000mg film-coated tablets (PL 36390/ ; ) could be approved. These products are prescription-only medicines indicated as: monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. adjunctive therapy o in the treatment of partial onset seizures with or without secondary generalisation in adults adolescents, children and infants from 1 month of age with epilepsy o in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy o in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy Levetiracetam is a pyrrolidone derivative, not chemically related to any existing antiepileptic active substances. The mechanism of action of levetiracetam is not fully understood, but in vitro studies showed that levetiracetam affects intraneuronal Ca 2+ levels and binds the synaptic vesicle protein 2A. Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures, and in man is proved to diminish epileptiform discharge and photoparoxysmal response. These applications were made under Article 10(1) of Directive 2001/83/EC, as amended, claiming to be generic medicinal products of the reference medicinal product Keppra 250, 500, 750 & 1000mg film-coated tablets, which were authorised to UCB Pharma SA via a Centralised Procedure that concluded in September 2000 (EU/1/00/146). The RMS for these procedures was the UK and the CMSs were Bulgaria, Cyprus, Czech Republic, Denmark, Greece, France, Croatia, Hungary, Ireland, Italy, Malta, Norway, Romania, Sweden, Slovenia and Slovak Republic. No new non-clinical studies were conducted, which is acceptable given that the applications are based on being generic medicinal products of the originator products that have been licensed for over 10 years. Since these products are intended for generic substitution, this will not lead to an increased exposure to the environment. An Environmental Risk Assessment (ERA) is, therefore, not deemed necessary. With the exception of one bioequivalence study, no new clinical data were provided with this application. A bioequivalence study was performed, which compared the pharmacokinetics of the applicant s Levetiracetam 1000mg film-coated tablets with those of the reference product, Keppra 1000mg film-coated tablets, in healthy subjects under fasting conditions. The bioequivalence study was conducted in-line with current Good Clinical Practice (GCP). The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for this product type at all sites responsible for the manufacture, assembly and batch release of these products. 5

6 For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates of satisfactory inspection summary reports, as certification that acceptable standards of GMP are in place at those non-community sites. A Risk Management Plan (RMP) and a summary of the pharmacovigilance system have been provided with these applications and are satisfactory. The RMS and CMSs considered that the applications could be approved at the end of procedure (Day 210) on 02 December After a subsequent national phase, a licence was granted in the UK on 19 January II QUALITY ASPECTS II.1 Introduction These applications are submitted according to Article 10(1) of Directive 2001/83/EC, as amended. The applicant has specified Keppra 250, 500, 750 & 1000mg film-coated tablets (UCB Pharma SA) as the EU reference medicinal products. Levetiracetam film-coated tablets are light blue (250mg), yellow (500mg), light pink (750mg) and white (1000mg), capsule-shaped, biconvex, film-coated tablets plain on both sides. Each tablet contains 250mg, 500mg, 750mg or 1000mg of the active substance levetiracetam. The excipients in each tablet are: maize starch, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and film coatings Opadry Blue (250mg), Opadry Yellow (500mg), Opadry Pink (750mg) and Opadry White (1000mg). The tablets are presented in polyvinylchloride (PVC), polyethylene (PE), polyvinylidene chloride (PVdC) and aluminium blisters. These are packaged into cardboard boxes in pack sizes of 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets. Not all pack sizes are marketed. 6

7 II.2 DRUG SUBSTANCE rinn: Levetiracetam Chemical Name: (S)- _-Ethyl-2-oxo-1-pyrrolidine acetamide 2(S)-(2-Oxopyrrolidin-1-yl) butyramide Structure: Molecular Formula: C8H14N2O2 Molecular Weight: Appearance: A white or almost white powder Solubility: Very soluble in water, soluble in acetonitrile, practically insoluble in hexane. Levetiracetam exhibits chirality and has optical rotation. All aspects of the manufacture and control of active levetiracetam are covered by a European Directorate for the Quality of Medicines (EDQM) certificate of suitability. II.3 DRUG PRODUCT Pharmaceutical development The objective of the pharmaceutical development was to produce tablets containing 250, 500, 750 and 1000mg levetiracetam that could be considered to be generic medicinal products of Keppra 250, 500, 750 & 1000mg film-coated tablets (UCB Pharma SA). Details of the pharmaceutical development of the medicinal products have been supplied and are satisfactory. Comparable dissolution and impurity profiles have been provided for these products versus their respective reference products. All excipients comply with their respective European Pharmacopoeia monographs with the exception of Opadry Blue, Opadry Yellow, Opadry, White and Opadry Pink, which are controlled to suitable in-house specifications. The colouring agents used comply with current EU regulations requirements. Satisfactory Certificates of Analysis have been provided for all excipients. Opadry Blue consists of the excipients hypromellose, titanium dioxide, Macrogol/PEG 400, and FD&C indigo carmine aluminium lake. Opadry Yellow consists of the excipients hypromellose, titanium dioxide, Macrogol/PEG 400, and yellow iron oxide. 7

8 Opadry Pink consists of the excipients hypromellose, titanium dioxide, Macrogol/PEG 400, red iron oxide, and FD&C yellow Sunset Yellow aluminium lake. Opadry White consists of the excipients hypromellose, titanium dioxide and Macrogol No excipients of animal or human origin are used in the final products. None of the excipients are sourced from genetically modified organisms. Manufacture of the product A description and flow-chart of the manufacturing method has been provided. Satisfactory batch formulae have been provided for the manufacture of the products, along with an appropriate account of the manufacturing process. The manufacturing process has been validated at commercial scale and has shown satisfactory results. The process validation protocol to be followed for full production-scale batches submitted is also satisfactory. Finished Product Specification The finished product specifications are satisfactory. Test methods have been described and adequately validated. Batch data have been provided and comply with the release specifications. Certificates of Analysis have been provided for any working standards used. Stability Finished product stability studies have been conducted in accordance with current guidelines, using batches of the finished products stored in the packaging proposed for marketing. Based on the results, a shelf-life of 2 years with no specific storage condition is satisfactory. Suitable post approval stability commitments have been provided. II.4 Discussion on chemical, pharmaceutical and biological aspects The grant of marketing authorisations is recommended. III NON-CLINICAL ASPECTS The pharmacodynamic, pharmacokinetic and toxicological properties of levetiracetam are well-established. As levetiracetam is a widely used, well-known active substance, the applicant has not provided additional studies and further studies are not required. An overview based on a literature review is, thus, appropriate. Suitable justification has been provided for non-submission of an Environmental Risk Assessment (ERA). As the application is for a generic version of an already authorised product, it is not expected that environmental exposure will increase following approval of the marketing authorisation for the proposed product. 8

9 IV Clinical aspects IV.1 Introduction With the exception of the below bioequivalence study, no new clinical data have been submitted for these applications. The applicant s clinical overview on the clinical pharmacology, efficacy and safety of the product has been written by an appropriately qualified person and is adequate. IV. 2 Pharmacokinetics In support of these applications, the marketing authorisation holder has submitted the following bioequivalence study: An open-label, randomised, two-way, crossover, single-dose bioequivalence study to compare the pharmacokinetics of the test product Levetiracetam 1000mg film-coated tablets versus the reference product Keppra 1000mg film-coated tablets (UCB Pharma SA) in healthy male subjects under fasted conditions. Volunteers received the test or reference treatment after an overnight fast. Blood samples were taken for the measurement of pharmacokinetic parameters pre-dose and up to 48 hours post dose. The two treatment periods were separated by a minimum 5-day washout period. The main pharmacokinetic results are presented below: The 90% confidence intervals were within the acceptance criteria of 80.00% %. Based on these results, the test product Levetiracetam 1000mg film-coated tablets can be considered to be bioequivalent with the reference product Keppra 1000mg film-coated tablets. As the 250, 500, 750 and 1000mg strengths of the product meet the criteria specified in the Notes for Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98), the extrapolation of results and conclusions from the bioequivalence study on the 1000mg strength to the other strengths is justified. Therefore, bioequivalence has been shown between the 250, 500, 750 and 1000mg strengths of product and their respective reference products. IV.3 Pharmacodynamics No new pharmacodynamic data are required for these applications and none have been submitted. IV.4 Clinical efficacy No new efficacy data were submitted with these applications and none were required. 9

10 IV.5 Clinical safety With the exception of the safety data collected during the bioequivalence study, no new safety data were submitted with these applications and none were required. No new unexpected treatment-related adverse events were observed during the trial. IV.6 Risk Management Plan (RMP) The marketing authorisation holder has submitted an RMP 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 Levetiracetam film-coated tablets. A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, are listed below. Important identified risks 10

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14 Important potential risks 14

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16 Missing information IV.7 Discussion on the clinical aspects The grant of marketing authorisations is recommended for these applications. V User consultation A user consultation with target patient groups on the PIL has been performed and the results submitted 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 it contains. VI Overall conclusion, benefit/risk assessment and recommendation The quality of the products is acceptable, and no new non-clinical or clinical safety concerns have been identified. The application includes an adequate review of published non-clinical and clinical data concerning the efficacy and safety of levetiracetam. The test products Levetiracetam 250, 500, 750 and 1000mg film-coated tablets can be considered bioequivalent 16

17 with the reference products Keppra 250, 500, 750 and 1000mg film-coated tablets. The benefit/risk assessment is, therefore, considered to be positive. The Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labelling are satisfactory, in line with current guidelines and consistent with the reference products. In accordance with Directive 2012/84/EU, the current approved UK versions of the SmPCs and PILs for this product is available on the MHRA website. The currently approved labels are listed below: 17

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