Public Assessment Report. Decentralised Procedure. Cefuroxime 250mg and 500mg film-coated tablets. Cefuroxime 500mg film-coated tablets

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1 Public Assessment Report Decentralised Procedure Cefuroxime 250mg film-coated tablets Cefuroxime 500mg film-coated tablets Procedure No: UK Licence No: PL 35646/ Alkem Pharma GmbH 1

2 LAY SUMMARY Cefuroxime 250mg film-coated tablets Cefuroxime 500mg film-coated tablets This is a summary of the Public Assessment Report (PAR) for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets. It explains how the applications for Cefuroxime 250mg filmcoated tablets and Cefuroxime 500mg film-coated 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 Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets. For practical information about using Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg filmcoated tablets, patients should read the package leaflet or contact their doctor or pharmacist. What are Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets and what are they used for? Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets are generic medicines. This means that they are similar to reference medicines already authorised in the European Union (EU) called Zinnat Tablets 250mg and Zinnat Tablets 500mg, which have been authorised since Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets are used to treat infections of the throat, sinus, middle ear, lungs or chest, the urinary tract and skin and soft tissues. The tablets can also be used to treat Lyme disease (an infection spread by parasites called ticks). A doctor may test the type of bacteria causing an infection and monitor whether the bacteria are sensitive to cefuroxime during the patient s treatment. How do Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets work? Cefuroxime is an antibiotic which works by killing bacteria that cause infections. It does this by stopping the synthesis of the bacteria s protective cell wall, causing cell death of the bacteria. How are Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets used? Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets should be taken after food. This helps to make the treatment more effective. The tablets should be swallowed whole with some water and should not be chewed, crushed or split as this may make the treatment less effective. The usual dose in adults is 250 mg to 500 mg twice daily depending on the severity and type of infection. The usual dose of in children is 10 mg/kg (to a maximum of 125 mg) to 15 mg/kg (to a maximum of 250 mg) twice daily depending on the severity and type of infection. Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets are not recommended for children aged less than 3 months, as the safety and effectiveness of cefuroxime are not known in this age group. The initial dose may be changed or more than one course of treatment may be needed, depending on the illness or how the patient responds to treatment. Patients with kidney problems may have their dose changed by their doctor. 2

3 It is important that patients complete the full course of treatment unless there are advised to stop taking the tablets by their doctor, even if they are feeling better, as the infection may come back. Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets can only be obtained with a prescription. What benefits of Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets have been shown in studies? Because Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets are generic medicines, studies in patients have been limited to tests to determine that the tablets are bioequivalent to the reference medicines, Zinnat Tablets 250mg and Zinnat Tablets 500mg. Two medicines are bioequivalent when they produce the same levels of active substance in the body. What are the possible side effects of Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets? Because Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets are generic medicines and are bioequivalent to the reference medicines, their benefits and possible side effects are taken as being the same as those of the reference medicines. Why are Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets approved? It was concluded that, in accordance with EU requirements, Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets have been shown to have comparable quality and to be bioequivalent to Zinnat Tablets 250mg and Zinnat Tablets 500mg. Therefore, the MHRA decided that, as for Zinnat Tablets 250mg and Zinnat Tablets 500mg, the benefits of Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets are greater than their risks and recommended that they can be approved for use. What measures are being taken to ensure the safe and effective use of Cefuroxime 250mg filmcoated tablets and Cefuroxime 500mg film-coated tablets? Safety information has been included in the Summaries of Product Characteristics and the package leaflet for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg 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/healthcare professionals will be monitored and reviewed continuously. Other information about Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets Marketing Authorisations were granted in the UK for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets on 15 July The full PAR for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets follows this summary. For more information about treatment with Cefuroxime film-coated tablets, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in September

4 SCIENTIFIC DISCUSSION TABLE OF CONTENTS I Introduction Page 5 II Quality aspects Page 6 III Non-clinical aspects Page 11 IV Clinical aspects Page 11 V User consultation Page 23 VI Overall conclusion, benefit/risk assessment and recommendation Page 24 Annex 1 - Table of content of the PAR update for MRP and DCP Page 25 4

5 Scientific discussion I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Competent Authorities of Germany, Spain and the UK considered that the applications for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets (PL 35646/ ; ) could be approved. These are prescription-only medicines (POMs). Cefuroxime film coated tablets are indicated for the treatment of the following infections in adults and children from the age of 3 months. Acute streptococcal tonsillitis and pharyngitis Acute bacterial sinusitis Acute otitis media Acute exacerbations of chronic bronchitis Cystitis Pyelonephritis Uncomplicated skin and soft tissue infections Treatment of early Lyme disease Consideration should be given to official guidance on the appropriate use of antibacterial agents. These applications were submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS), and Germany and Spain as Concerned Member States (CMS). The applications for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets were submitted under Article 10(1) of Directive 2001/83/EC, as amended, as generic applications. The reference products authorised in the EU for not less than 6/10 years are Zinnat Tablets 250mg (PL 10949/0096) and Zinnat Tablets 500mg (PL 10949/0119), authorised to GlaxoSmithKline UK following change of ownership procedures on 1 February 1994 and 1 November 1993, respectively. Prior to this both reference products were authorised to Glaxo Operations UK Limited; Zinnat Tablets 250mg (PL 0004/0318) were first authorised on 3 September 1987 and Zinnat Tablets 500mg (PL 00004/0335) were first authorised on 18 August The reference product used in the bioequivalence study is Zinnat 500mg film-coated tablets, which was authorised in Hungary to GlaxoSmithKline Hungary on 31 January Cefuroxime axetil undergoes hydrolysis by esterase enzymes to the active antibiotic, cefuroxime. Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death. No new non-clinical data were submitted, which is acceptable given that the applications are for generic medicinal products of originator products that have been in clinical use for over 10 years. The applicant has submitted a report of one bioequivalence study. Assurance has been provided that the study has been conducted according to the principles of Good Clinical Practice (GCP). The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for these product types at all sites responsible for the manufacture and assembly of these products. 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 5

6 has accepted copies of current GMP Certificates of 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. The RMS considers that the pharmacovigilance system, as described by the MA holder, fulfils the requirements and provides adequate evidence that the MA holder has 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. The MA holder has provided a Risk Management Plan (RMP). The lack of an Environmental Risk Assessment (ERA) with these applications for generic products is acceptable. The UK, Germany and Spain considered that the applications could be approved on day 205 of the procedure, on 17 June After a subsequent national phase, Marketing Authorisations were granted to Alkem Pharma GmbH in the UK on 15 July II QUALITY ASPECTS II.1 Introduction The 250mg and 500mg tablets are blue, capsule-shaped, biconvex, film-coated and debossed with `204` and `203`, respectively. The tablets contain 250mg or 500mg cefuroxime (as cefuroxime axetil) and the excipients microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, colloidal anhydrous silica, calcium stearate, calcium carbonate and crospovidone. The colorant used to make the tablets is composed of hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520), FD &C blue no. 1 aluminium lake E133. The tablets are presented in aluminium foil blister packs with an aluminium film. Pack sizes of 2, 6, 10, 12, 14, 24 and 50 tablets have been authorised, although not all packs may be marketed. II.2 DRUG SUBSTANCE CEFUROXIME INN: Chemical name: Structure: Cefuroxime axetil (1RS)-1-(acetyloxy) ethyl (6R, 7R)-3-[(carbamoyloxy) methyl]-7-[[(z)-2- (furan-2-yl)-2-(methoxyimino) acetyl] amino ]-8-oxo-5-thia-1-azabicyclo [ 4.2.0] oct-2-ene-2-carboxylate CAS number: Molecular formula: C 20 H 22 N 4 O 10 S Molecular weight:

7 With the exception of stability studies undertaken by the drug substance manufacturer, all aspects of the manufacture and control of cefuroxime are covered by a European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability. Appropriate stability data have been generated to support a suitable retest period when stored in the proposed packaging. II.3 MEDICINAL PRODUCTS Pharmaceutical Development The aim of the pharmaceutical development of Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets was to develop generic versions of the innovator products, Zinnat Tablets 250mg and Zinnat Tablets 500mg. All the excipients comply with their respective European Pharmacopoeia monographs with the exception of the hypromellose (E464), titanium dioxide (E171), propylene glycol (E1520) and FD &C blue no. 1 aluminium lake E133, which are controlled in line with suitable in-house specifications. Satisfactory Certificates of Analysis have been provided for all excipients. None of the excipients contain materials of animal or human origin. Manufacturing Process Satisfactory batch formulae have been provided for the manufacture of the medicinal products, along with an appropriate account of the manufacturing process. The manufacturing process has been validated with pilot scale batches has shown satisfactory results. A commitment to validate the first three commercial batches is provided and is accepted. Control of Finished Products The finished product specifications are acceptable. Test methods have been described and have been validated adequately. Batch data have been provided that comply with the release specifications. Certificates of Analysis have been provided for all working standards used. Stability of the Products Finished product stability studies were performed in accordance with current guidelines on batches of finished product in the packaging proposed for marketing. Based on the results, a shelf-life 2 years is acceptable, when the storage precaution store below 25 C is applied. II.4 Discussion on chemical, pharmaceutical and biological aspects It is recommended that Marketing Authorisations are granted for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets. II.5 Summaries of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels The SmPCs, PIL and labelling are satisfactory and, where appropriate, in line with current guidance. In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) for products granted Marketing Authorisations at a national level are available on the MHRA website. The following text is the approved label text. 7

8 Cefuroxime 250mg film-coated tablets Blisters/strips: Outer carton: 8

9 Cefuroxime 500mg film-coated tablets Blisters/strips: 9

10 Outer carton: 10

11 III NON-CLINICAL ASPECTS III.1 Introduction The pharmacodynamic, pharmacokinetic and toxicological properties of cefuroxime are well known. No new non-clinical data have been submitted for these applications and none are required. The applicant has provided an overview based on published literature. The non-clinical overview has been written by an appropriately qualified person and is satisfactory, providing an appropriate review of the relevant non-clinical pharmacology, pharmacokinetics and toxicology. III.2 Pharmacology Not applicable, see Section III.1 Introduction, above. III.3 Pharmacokinetics Not applicable, see Section III.1 Introduction, above. III.4 Toxicology Not applicable, see Section III.1 Introduction, above. III.5 Ecotoxicity/Environmental Risk Assessment (ERA) Suitable justification has been provided for non-submission of an Environmental Risk Assessment. As the products are intended for generic substitution with products that are already marketed, no increase in environmental exposure to cefuroxime is anticipated. Thus, the justification for non-submission of an Environmental Risk Assessment is accepted. III.6 Discussion of the non-clinical aspects It is recommended that Marketing Authorisations are granted for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets. IV CLINICAL ASPECTS IV.1 Introduction The applicant has submitted reports of one bioequivalence study in support of these applications. The applicant s clinical overview has been written by an appropriately qualified person and is considered acceptable. IV.2 Pharmacokinetics An open label, balanced, pivotal, laboratory blind, randomised, two-period, two-treatment, twosequence, single dose, two-way crossover, bioequivalence study was conducted comparing Cefuroxime 500mg film-coated tablets with Zinnat Tablets 500mg in healthy, adult, male, human subjects under fed conditions. Blood samples were collected from each subject in each period at pre-dose and at intervals up to up to 10 hours following drug administration. The plasma samples from the subjects were analysed for cefuroxime using a validated method. The drug administrations were separated by a wash-out period of 8 days. Samples from 28 subjects were considered in the PK analysis and the results are presented below: 11

12 The 90% confidence intervals for AUC and C max were within the acceptance range of to %. Bioequivalence between Cefuroxime 500mg film-coated tablets with Zinnat Tablets 500mg has been adequately demonstrated. As the 250mg and 500mg strengths of the product meet the criteria specified in the guideline on investigation of bioequivalence, the extrapolation of results and conclusions from the bioequivalence study on the 500mg strength to the 250mg strength is justified. Therefore, bioequivalence has been shown between Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets 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 clinical efficacy data are required for these applications and none have been submitted. IV.5 Clinical safety With the exception of the data generated during the bioequivalence study, no new safety data are presented for these applications and none are required. No new or unexpected safety issues arose during the bioequivalence study. IV.6 Risk Management Plan (RMP) The applicant has submitted a risk management plan (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 Cefuroxime film-coated tablets. Routine pharmacovigilance activities and risk minimisation measures should be adequate for this product, which contains a widely used active substance with a well-established safety profile. A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, is listed below: 12

13 13

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15 15

16 16

17 17

18 18

19 19

20 20

21 21

22 22

23 IV.7 Discussion of the clinical aspects It is recommended that Marketing Authorisations are granted for Cefuroxime 250mg film-coated tablets and Cefuroxime 500mg film-coated tablets. IV. 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 language used for the purpose of user testing the pack leaflet was English. 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. 23

24 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. Extensive clinical experience with cefuroxime is considered to have demonstrated the therapeutic value of the compound. The benefit/risk balance is, therefore, considered to be positive. 24

25 Annex 1 - Table of content of the PAR update for MRP and DCP Steps Taken After The Initial Procedure With An Influence On The Public Assessment Report (Type II variations, PSURs, commitments) Scope Procedure number Product Information affected Date of start of the procedure Date of end of procedure Approval / non approval Assessme nt report attached Y/N (version) 25

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