Public Assessment Report. Decentralised Procedure

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1 Public Assessment Report Decentralised Procedure Linezolid 2 mg/ml solution for infusion Linezolid 600mg film coated tablets Linezolid 100mg/5ml granules for oral suspension Procedure No: UK Licence No: PL 00057/ Pfizer Limited

2 LAY SUMMARY On 24 October 2012, Belgium, Finland, Luxembourg and the UK agreed to grant Marketing Authorisations to Pfizer Limited for the medicinal products Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/ ; ). The licences were granted via the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS). After the national phase, Marketing Authorisations were granted in the UK on 23 November Linezolid is an antibiotic of the oxazolidinones group that works by stopping the growth of certain bacteria (germs) that cause infections. It is used to treat pneumonia and some infections in the skin or under the skin. No new or unexpected safety concerns arose from these applications and it was therefore judged that the benefits of taking Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets outweigh the risks; hence, Marketing Authorisations were granted. 2

3 TABLE OF CONTENTS Module 1: Information about initial procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Patient Information Leaflets Page 6 Module 4: Labelling Page 7 Module 5: Scientific Discussion Page 15 I Introduction II About the Product III Scientific Overview and Discussion III.1 Quality aspects III.2 Non-clinical aspects III.3 Clinical aspects IV Overall conclusion Module 6 Steps taken after initial procedure Page 21 Annex 1 Clinical Variation Assessment Report Page 22 3

4 Module 1 Product Names Type of Application Active Substances Form and strength MA Holder Reference Member State (RMS) Concerned Member States (CMS) Procedure Number Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets Simple abridged, Article 10c Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom UK Belgium, Finland Luxembourg Timetable Day November

5 Module 2 Summary of Product Characteristics The current approved UK versions of the Summaries of Product Characteristics (SmPC) for these products are available on the MHRA website. 5

6 Module 3 Patient Information Leaflet The current approved UK versions of the Patient Information Leaflets (PIL) for these products are available on the MHRA website. 6

7 Module 4 Labelling 7

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15 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 Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/ ; UK/H/5156/001-3/DC) could be approved. These applications were submitted via the Decentralised Procedure, with the UK as Reference Member State (RMS), and Belgium, Finland and Luxembourg as Concerned Member States (CMS). These are prescription-only medicines indicated for the treatment of community-acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram-positive bacteria. It is also indicated for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria. These are applications made under the Decentralised Procedure (DCP), according to Article 10c of Directive 2001/83/EC, as amended, abridged simple applications referring to Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/ ), which were originally granted to Pharmacia Limited on 5 January Linezolid selectively inhibits bacterial protein synthesis via a unique mechanism of action. Specifically, it binds to a site on the bacterial ribosome (23S of the 50S subunit) and prevents the formation of a functional 70S initiation complex, which is an essential component of the translation process. The RMS has been assured that acceptable standards of Good Manufacturing Practice are in place for these product types at all sites responsible for the manufacture, assembly and batch release of these products. The RMS and CMS considered that the application could be approved with the end of procedure (Day 210) on 24 October After a subsequent national phase, the licence was granted in the UK on 23 November

16 II. 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) Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets Linezolid Other antibacterials (J01 XX) 100mg/5ml granules for oral suspension, 2mg/ml solution for infusion and 600mg film-coated tablets Reference numbers for the Mutual Recognition Procedure Reference Member State United Kingdom Member States concerned Belgium, Finland, Luxembourg Marketing Authorisation Number(s) PL 00057/ Name and address of the authorisation holder Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom 16

17 III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS 1. INTRODUCTION These are simple, piggyback applications for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/ ; ) submitted under Article 10c (formerly Article 10.1(a)(i)) of Directive 2001/83/EC. The proposed MA holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom. The applications cross-refer to Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/ ), which were originally granted to Pharmacia Limited on 5 January The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides adequate evidence that the applicant 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. A suitable Risk Management Plan (RMP) has been provided. A suitable justification has been provided for non-submission of an Environmental Risk Assessment (ERA). As these products are intended for substitution with products that are already currently marketed, there is considered to be no increase in environmental burden and an RMP is not considered necessary. The current applications are considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 Name(s) The proposed name of the products is Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets. The products have been named in-line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes Linezolid 2mg/ml Solution for Infusion (PL 00057/1418): 300ml solution packed in a latex-free polyolefine film infusion bags sealed inside a foil laminate overwrap and packed in a box. Each box contains 1, 2, 3, 5, 6, 10, 20 or 25 infusion bags. The shelf-life (3 years) and storage conditions (before opening: Store in the original package (overwrap and carton) until ready to use; after opening: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user) are consistent with the details registered for the cross-reference product. Linezolid 600mg Film-Coated Tablets (PL 00057/1419): 10, 14, 20, 24, 30, 50, 60 or 100 tablets, packaged in white high-density polyethylene bottles, with polypropylene screw caps. Polyvinylchloride/aluminium blisters containing 10, 20, 30, 50, 60 and 100 tablets. The proposed shelf-life (3 years) and storage conditions (none) are consistent with the details registered for the cross-reference product. 17

18 Linezolid 100mg/5ml Granules for Oral Suspension (PL 00057/1420): 66g of granules for oral suspension in an amber Type III glass bottles (240ml), with polypropylene, child-resistant screw cap and a 2.5ml/5ml measuring spoon. The bottles are packed into boxes in pack sizes of 1, 5 or 10 bottles. The proposed shelf-life (2 years before reconstitution and 3 weeks after reconstitution) and storage conditions ( Keep the container tightly closed before reconstitution and Keep container in outer carton after reconstitution) are consistent with the details registered for the cross-reference product. 2.3 Legal status On approval, the products will be available as prescription-only medicines (legal status POM). 2.4 Marketing authorisation holder/contact Persons/Company Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom. The QP responsible for pharmacovigilance is stated and his CV is included. 2.5 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference products and evidence of Good Manufacturing Practice (GMP) compliance has been provided. 2.6 Qualitative and quantitative composition The proposed composition is consistent with the details registered for the cross-reference products. 2.7 Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross-reference products and the maximum batch sizes are stated. 2.8 Finished product/shelf-life specification The proposed finished product specifications are in line with the details registered for the cross-reference products. 2.9 Drug substance specification The proposed drug substance specification is consistent with the details registered for the cross-reference product TSE Compliance No materials of animal or human origin are included in these products. This is consistent with the cross-reference products. 3. EXPERT REPORTS The applicant has included detailed expert reports in Module 2 of the application. Signed declarations and copies of the experts CVs are enclosed in Module 1.4 for the quality, non-clinical and clinical experts. All are considered to have sufficient experience for their responsibilities. 18

19 4. PRODUCT NAME & APPEARANCE See 2.1 for details of the proposed product name. The appearance of the products is identical to the cross-reference products. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The proposed SmPCs are consistent with the details registered for the cross-reference products. 6. PATIENT INFORMATION LEAFLET (PIL)/CARTON PIL The patient information leaflet has been prepared in-line with the details registered for the cross-reference products. Carton and blister The proposed artwork is comparable to the artwork registered for the cross-reference products and complies with statutory requirements. In-line with current legislation, the applicant has also included the name of the product in Braille on the outer packaging and has included sufficient space for a standard UK pharmacy dispensing label. 7. CONCLUSIONS The data submitted with these applications are acceptable. From a quality perspective, Marketing Authorisations should be granted. III.2 NON-CLINICAL ASPECTS No new non-clinical data have been supplied with these applications and none are required for applications of this type. III.3 CLINICAL ASPECTS No new clinical data have been supplied with these applications and none are required for applications of this type. IV OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT QUALITY Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/ ; ) are identical to the already licensed reference products. The products are, therefore, pharmaceutically satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. CLINICAL PHARMACOLOGY/EFFICACY No new clinical pharmacology/efficacy data have been submitted with these applications and none are required for applications of this type. SAFETY No new safety data have been submitted with these applications and none are required for applications of this type. No new or unexpected safety concerns arise from these applications. The SmPCs, PIL and labelling are satisfactory. 19

20 BENEFIT-RISK ASSESSMENT The quality of the products is acceptable and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with linezolid is considered to have demonstrated the therapeutic value of the compound. The benefit/risk is, therefore, considered to be positive. 20

21 Module 6 Linezolid granules, film-coated tablets and solution for infusion PL 00057/ STEPS TAKEN AFTER ASSESSMENT Date Application submitted type 06/12/2012 VAR Medical Type II Description To update section 4.6 (pregnancy and lactation) of the SmPC following the Post Marketing Commitment after Day 160 end of procedure. As a consequence, the PIL has been updated. Outcome Variation granted 23/09/

22 ANNEX 1 CLINICAL VARIATION ASSESSMENT REPORT RECOMMENDATION Based on the review of the data provided, the Reference Member State (RMS) considers that the variation application is approvable. EXECUTIVE SUMMARY Scope of the variation This variation seeks approval for modifications to the Summary of Product Characteristics (SmPC) and Patient information leaflet (PIL) for the following products: Linezolid 2 mg/ml solution for infusion Linezolid 100 mg/5 ml granules for oral suspension Linezolid 600 mg film-coated tablets The proposed changes satisfy the post-marketing commitment made during procedures UK/H/5156/01-03/DC, whereby QRD standard headings and wording relating to section 4.6 of the SmPC and section 2 of the PIL have been added. In addition, standard headings have been modified in sections 4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.5 and 6.6 of the SmPCs for the Film-coated tablets and Granules for Oral Suspension. SCIENFIC DISCUSSION Product information Summary of Product Characteristics During the course of the decentralised procedures UK/H/5156/01-03/DC, the Marketing Authorisation Holder (MAH) committed to revising Section 4.6 of the SmPC to include the relevant conclusions from fertility studies. The applicant has proposed the following text for Section 4.6 of the SmPC for the three products containing Linezolid. 4.6 Fertility, pregnancy and lactation Pregnancy There are no adequate data from the use of linezolid in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). A potential risk for humans exists. Linezolid should not be used during pregnancy unless clearly necessary i.e. only if the potential benefit outweighs the theoretical risk. Breast-feeding Animal data suggest that linezolid and its metabolites may pass into breast milk and, accordingly, breast-feeding should be discontinued prior to and throughout administration. 22

23 Fertility In animal studies, linezolid caused a reduction in fertility (see section 5.3). The standard headings have also been modified in sections 4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.5 and 6.6 of the SmPCs for the Film-coated tablets and Granules for Oral Suspension, which is acceptable. Package leaflet Revisions have been made to the pregnancy, breast-feeding and fertility subsection within Section 2 of the PIL. However, minor amendments were requested as outlined in tracked changes below: Pregnancy, breast-feeding and fertility The effect of Linezolid in pregnant women is not known. Therefore, it should not be taken in pregnancy unless advised by your doctor. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not breast-feed when taking Linezolid because it passes into breast milk and could affect the baby. SUMMARY Amendments to the SmPC and PIL for Linezolid 2 mg/ml solution for infusion, Linezolid 100 mg/5 ml granules for oral suspension and Linezolid 600 mg film-coated tablets have been proposed by the MAH. These changes were made in order to satisfy a post-approval commitment concerning the decentralised procedures UK/H/5156/01-03/DC. Further amendments to Section 4.6 of the SmPC and the pregnancy, breast-feeding and fertility subsection of the PIL were requested (as outlined in Section II of this report) prior to the approval of this variation. ASSESSMENT OF THE RESPONSES The applicant has provided the responses and the changes to the SmPC and the PIL have been made as proposed. Hence Section 4.6 of the SmPC now been amended as follows: 4.6 Fertility, pregnancy and lactation Pregnancy There are no adequate data from the use of linezolid in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). A potential risk for humans exists. Linezolid should not be used during pregnancy unless clearly necessary i.e. only if the potential benefit outweighs the theoretical risk. Breast-feeding Animal data suggest that linezolid and its metabolites may pass into breast milk and, accordingly, breastfeeding should be discontinued prior to and throughout administration. 23

24 Fertility In animal studies, linezolid caused a reduction in fertility (see section 5.3). The corresponding section of the PIL has been amended as follows: Pregnancy, breast-feeding, and fertility The effect of Linezolid in pregnant women is not known. Therefore it should not be taken in pregnancy unless advised by your doctor. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not breast-feed when taking Linezolid because it passes into breast milk and could affect the baby. OVERALL CONCLUSION The variation was approved on 23 rd September 2013 and the updated SmPCs fragment and the PILs have been incorporated into these Marketing Authorisations. The proposed changes are acceptable. The current approved UK version of the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for these products are available on the MHRA website. 24

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