Public Assessment Report. Decentralised Procedure

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1 Public Assessment Report Decentralised Procedure Linezolid Pfizer 2 mg/ml Solution for Infusion Linezolid Pfizer 100 mg/5 ml Granules for Oral Suspension Procedure No: UK/H/5515/ /DC UK Licence No: PL 00057/ Pfizer Limited

2 Lay Summary Linezolid Pfizer 2 mg/ml Solution for Infusion (linezolid) This is a summary of the public assessment report (PAR) for Linezolid Pfizer 2 mg/ml Solution for Infusion, and Linezolid Pfizer 100 mg/5 ml Granules for Oral Suspension (PL 00057/ ; UK/H/5515/ /DC). Linezolid Pfizer 2 mg/ml Solution for Infusion, and will be referred to as Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension, respectively throughout this report, for ease of reading. It explains how Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension 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 these Linezolid products. For practical information about using Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension, patients should read the package leaflet or contact their doctor or pharmacist. What are Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension and what are they used for? Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are generic medicines that are identical to reference medicines, already authorised in the European Union (EU) called Zyvox 2 mg/ml solution for infusion, Zyvox 600 mg film-coated tablets and Zyvox 100 mg/5 ml Granules for oral suspension, respectively. Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are used to treat pneumonia and some infections in the skin or under the skin. The prescribing doctor will decide if these medicines are suitable to treat the infection. How do Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension work? Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension contain the active substance linezolid, which is an antibiotic of the oxazolidinones group that works by stopping the growth of certain bacteria (germs) that cause infections. How are Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension used? Linezolid 2 mg/ml infusion will be given to the patient as an infusion into a vein by a drip, which will be given by a doctor or healthcare professional. For adults the usual dose is 300 ml (600 mg linezolid) given twice daily, over a period of 30 to 120 minutes. Linezolid 600 mg tablets should be swallowed whole with some water. For adults the usual dose is one tablet (600 mg linezolid) twice daily (every twelve hours). 2

3 Linezolid 100 mg/5 ml Granules for Oral Suspension come as granules, which will be made up exclusively by the pharmacist; they will make a suspension for the patient to take. For adults the usual dose of this suspension is six 5 ml spoonfuls (600 mg linezolid), twice daily (every 12 hours). (Before use, the bottle should be turned upside down a few times but not shaken). A course of treatment for each of the three medicines listed above usually lasts 10 to 14 days but can last up to 28 days. Linezolid is not usually used in children and adolescents under 18 years old. Please read Section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration and the duration of treatment. These medicines can only be obtained with a prescription. How have Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension been studied? Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are considered identical to the reference medicines, Zyvox 2 mg/ml solution for infusion, Zyvox 600 mg film-coated tablets and Zyvox 100 mg/5 ml Granules for oral suspension, respectively, with the same benefits and risks. No new studies have, therefore, been provided for Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension but reference is made to the studies for Zyvox 2 mg/ml solution for infusion, Zyvox 600 mg film-coated tablets and Zyvox 100 mg/5 ml Granules for oral suspension, respectively. What are the possible side effects of Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension? Because Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are generic medicines, their benefits and possible side effects are taken as being the same as the reference medicines, Zyvox 2 mg/ml solution for infusion, Zyvox 600 mg film-coated tablets and Zyvox 100 mg/5 ml Granules for oral suspension, respectively. For further information, please see the package leaflet. Why are Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension approved? It was decided that the benefits of Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension outweigh the identified risks and it was recommended that these products be approved for use. What measures are being taken to ensure the safe and effective use of Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension? A Risk Management Plan (RMP) has been developed to ensure that Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are used as safely as possible. Based on this plan, safety information has been included in the Summaries of Product Characteristics (SmPC) and the package leaflets for these 3

4 products, 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 Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension Austria, Belgium, France, Germany, Greece, Italy, Ireland, Netherlands, Portugal and the UK agreed to grant marketing authorisations to Pfizer Limited for Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension on 21 December The marketing authorisations in the UK were granted on 23 January The full PAR for Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension follows this summary. For more information about the use of Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in March

5 Table of Contents I Introduction Page 6 II Quality aspects Page 8 III Non-clinical aspects Page 11 IV Clinical aspects Page 12 V User consultation Page 14 VI Overall conclusion, benefit/risk assessment and recommendation Page 15 Table of content of the PAR update for MRP and DCP Page 27 5

6 I Introduction Based on the review of the data on quality, safety and efficacy, the Member States have granted marketing authorisations (MAs) to Pfizer Limited for the medicinal products Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension. These products are prescription-only medicines (legal status POM). Linezolid is indicated in adults for the treatment of: - community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria. In determining whether Linezolid is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Gram positive bacteria should be taken into consideration (see section 5.1 for the appropriate organisms). Linezolid is not active against infections caused by Gram negative pathogens. Specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected. - complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria. Linezolid is not active against infections caused by Gram negative pathogens. Linezolid should only be used in patients with complicated skin and soft tissue infections with known or possible co-infection with Gram negative organisms if there are no alternative treatment options available (see section 4.4). In these circumstances treatment against Gram negative organisms must be initiated concomitantly. Use of Linezolid should only be initiated in a hospital environment and after consultation with a relevant specialist such as a microbiologist or infectious diseases specialist. 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 Austria, Belgium, France, Germany, Greece, Italy, Ireland, Netherlands and Portugal as Concerned Member States (CMSs). These applications were made under Article 10(1) of Directive 2001/83/EC, as amended, claiming to be generic medicinal products. The reference medicinal products, which have been authorised in accordance with Community provisions in force for not less than 10 years in the European Economic Area are Zyvox 2 mg/ml solution for infusion, Zyvox 600 mg film-coated tablets and Zyvox 100 mg/5 ml Granules for oral suspension; these products were each authorised to Pharmacia Limited in the UK on 05 January 2001 (PL 00032/0259, PL 00032/0261 and PL 00032/0262, respectively). Zyvox 2 mg/ml solution for infusion subsequently underwent a change in ownership procedure from the original MA Holder, Pharmacia Limited, to Pfizer Limited on 07 November 2014 (PL 00057/1066). Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension contain the active ingredient linezolid. Linezolid is a synthetic, 6

7 antibacterial agent that belongs to a class of antimicrobials called oxazolidinones. It has in vitro activity against aerobic Gram positive bacteria and some anaerobic micro-organisms. Linezolid selectively inhibits bacterial protein synthesis by binding to a site on the bacterial ribosome (23S of the 50S subunit) and preventing the formation of a functional 70S initiation complex, which is an essential component of the translation process. No new non-clinical studies were conducted, which is acceptable given that the applications are based on being generic medicinal products of originator products that have been licensed for over 10 years. Since Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension 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. These applications contain Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension have the same qualitative and quantitative composition of active substance and pharmaceutical forms as the currently authorised reference products, Zyvox 2mg/ml Solution for Infusion, Zyvox 600mg film-coated tablets and Zyvox 20 mg/ml granules for oral suspension. The applicant has provided a statement that the reference and proposed products are identical and the manufacturing chain proposed for the generic products is the same as that approved for the reference products. No new data on the pharmacokinetics and pharmacodynamics of the active substance linezolid have been included in these applications and no bioequivalence studies have been undertaken comparing the bioavailability of the proposed products to the reference products. This is acceptable. 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, assembly and batch release 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 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 application could be approved at the end of procedure (Day 210) on 21 December After a subsequent national phase, a licence was granted in the UK on 23 January

8 II Quality aspects II.1 Introduction These applications are submitted according to Article 10(1) of Directive 2001/83/EC, as amended. The proposed products have the same qualitative and quantitative composition of active substance and pharmaceutical forms as the currently authorised reference products, Zyvox 2mg/ml Solution for Infusion (PL 00057/1066), Zyvox 600mg film-coated tablets (PL 00032/261) and Zyvox 20 mg/ml granules for oral suspension (PL 00032/0262). - Linezolid 2 mg/ml infusion is formulated as an isotonic, clear, colourless to yellow solution for infusion with ph range of 4.4 to ml contains 2 mg linezolid. A 300 ml infusion bag contains 600 mg linezolid. The excipients present in the formulation are: glucose monohydrate, sodium citrate (E331), citric acid anhydrous (E330) and water for injections. The solution for infusion is presented in single use, ready-to-use, latex-free, multilayered polyolefine film infusion bags, sealed inside a foil laminate overwrap. The bag holds 300 ml solution and is packaged in a box. Each box contains 1, 2, 5, 10, 20 or 25 infusion bags. - Linezolid 600 mg tablets are formulated as white, ovaloid tablets, 7.22 mm in length, 3.75 mm in width and 2.5 mm in thickness. Each tablet is printed with LZD 600 on one side and G on the other. Each tablet contains 600 mg linezolid. The excipients present in the tablet core are: microcrystalline cellulose (E460), maize starch, sodium starch glycollate type A, hydroxypropylcellulose (E463) and magnesium stearate (E572). The excipients present in the Opadry white film-coat are: hypromellose (E464), titanium dioxide (E171), Macrogol 400, carnauba wax (E903) and red ink (red iron oxide (E172), shellac glaze in alcohol, purified water, 2-ethoxyethanol (2-EE), propylene glycol and ammonium hydroxide). The tablets are presented in polyvinylchloride (PVC)/foil blisters of 10 tablets packed into cartons in pack sizes of 10, 20, 30, 50, 60 or 100 (for hospital use only) tablets. - Linezolid 100 mg/5 ml Granules for Oral Suspension are formulated as white to light-yellow, orange flavoured granules for oral suspension. Following reconstitution with 123 ml water, each 5 ml contains 100 mg linezolid. The excipients are: sucrose, mannitol (E421), microcrystalline cellulose (E460), carboxymethylcellulose sodium (E466), aspartame (E951), anhydrous colloidal silica (E551), sodium citrate (E331), xanthan gum (E415), sodium benzoate (E211), citric acid anhydrous (E330), sodium chloride, sweeteners (fructose, maltodextrin, monoammonium glycyrrhizinate, sorbitol) and orange, cream, peppermint and vanilla flavourings. For more details of the flavouring compositions please see the SmPC. The granules for oral suspension are presented in amber, Type III glass bottles with a nominal volume of 240 ml containing 66 g granules for oral suspension. Each bottle has a polypropylene, child resistant screw cap and is packaged in a box with 2.5 ml/5 ml measuring spoon. 8

9 II.2 Drug Substance Linezolid INN: Chemical Name: Structure: Linezolid (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- oxazolidinyl]methyl]-acetamide Molecular formula: C 16 H 20 FN 3 O 4 Molecular weight: Appearance: White to off-white, crystalline powder Linezolid is not the subject of a European Pharmacopoeia (Ph Eur) monograph. Synthesis of the active 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. No materials of animal or human origin are used in the production of the active substance. Appropriate proof-of-structure data have been supplied for the active substance. All potential impurities have been identified and monitored appropriately. An appropriate specification is provided for the active substance. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Batch analysis data are provided and comply with the proposed specification. Satisfactory Certificates of Analysis have been provided for all working standards. Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with food. Appropriate stability data have been generated supporting a suitable retest period when stored in the proposed packaging. II.3 Medicinal Product Pharmaceutical development The applicant provides a statement that the manufacturing chains proposed for Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are identical to those of the reference products, Zyvox 2 mg/ml Solution for Infusion, Zyvox 600mg film-coated tablets and Zyvox 20 mg/ml granules for oral 9

10 suspension, respectively. The manufacture of the active ingredient and finished products of Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are, therefore, identical to the reference products. Historical information for the reference drug products has been presented. A statement is provided that the formulation and manufacturing chain of the proposed products is identical to those of the respective reference products. Dissolution profiles will, therefore, be identical to the reference products and bioequivalence studies were not performed. In accordance with CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** general biowaiver criteria are applied and the omission of bioequivalence studies are considered acceptable. All of the excipients used in the manufacture of Linezolid 2 mg/ml infusion comply with their respective European Pharmacopoeia monographs. All of the excipients used in the manufacture of Linezolid 600 mg tablets, with the exception of the Opadry white film coating, Opacode red printing ink and alcohol, meet the requirements of the current European Pharmacopoeia. Opadry white film coating, Opacode red printing ink and alcohol are controlled by satisfactory in-house specifications. All of the excipients used in the manufacture of Linezolid 100 mg/5 ml Granules for Oral Suspension, with the exception of the flavourings and sweeteners, meet the requirements of the current European Pharmacopoeia. The sweeteners (fructose, maltodextrin, monoammonium glycyrrhizinate, sorbitol) and orange, cream, peppermint and vanilla flavourings are controlled by satisfactory in-house specifications. Satisfactory Certificates of Analysis have been provided for all excipients showing compliance with their proposed specifications. None of the excipients are sourced from animal or human origin. It has been confirmed that magnesium stearate is prepared from stearic acid of vegetable origin. No genetically modified organisms (GMO) have been used in the preparation of this product. Manufacture of the product Satisfactory batch formulae have been provided for the manufacture of these finished products, together with an appropriate account of each manufacturing process. Satisfactory process validation was performed for the manufacturing processes. Product Specifications The finished product specification is satisfactory. Satisfactory batch analysis was performed on three batches of commercial scale batches of the finished product. Certificates of Analysis have been provided for all working standards used. Stability of the product Stability studies were performed in accordance with current guidelines on batches of the finished products, packed in the packaging proposed for marketing. The data from these studies support the following shelf lives and storage conditions: - Linezolid 2 mg/ml infusion - a shelf-life of 3 years before opening. From a microbiological point of view, unless the method of opening precludes the risk of 10

11 microbial contamination, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user. The storage conditions for the unopened product are Store in the original package (overwrap and carton) until ready to use, in order to protect from light. - Linezolid 600 mg tablets - a shelf life of 3 years. There are no special storage conditions. - Linezolid 100 mg/5 ml Granules for Oral Suspension - a shelf life of 2 years before reconstitution and 3 weeks after reconstitution. The storage conditions before reconstitution are keep the bottle tightly closed and after reconstitution, keep the bottle in the outer carton. Suitable post approval stability commitments have been provided. II.4 Discussion on chemical, pharmaceutical and biological aspects The grant of marketing authorisations is recommended for these applications. III Non-clinical aspects The non-clinical aspects of the reference products has been previously reviewed and assessed and consent has been given by the existing marketing authorisation holder to use their data in support of these current applications. The Applicant has provided no new non-clinical studies and none are required for this application. The Applicant has provided a review of non-clinical aspects of linezolid, which is acceptable. The applicant s non-clinical overview has been written by an appropriately qualified person. The non-clinical overview on the pharmacology, pharmacokinetics and toxicology is adequate. In the non-clinical documentation, there was no mention of the genotoxic potential of several drug substance impurities referred to in the quality section of the dossier. The applicant was asked to comment on the toxicological qualification of the impurities in response to a question raised by the authorities in Germany DE at Day 145. The applicant provided a response but this was not considered adequate. The applicant has been asked to meet the following post-approval commitments: - A commitment that additional testing should be provided within 3 months following approval to determine that the levels of potential genotoxic impurities are suitably controlled and either below the Threshold of Toxicological Concern (TTC) limit or suitably qualified. If absence of any potentially genotoxic compound in the final drug substance or in an intermediate is claimed, this needs to be demonstrated by corresponding analytical results from at least 6 consecutive pilot batches or 3 consecutive production size batches. The analytical method used should be capable of detecting the analyte at least at half of the concentration corresponding to the TTC of the substance (or sum of substances, if the same alerting structure is contained in more than one substance). 11

12 - A commitment to tighten the limit for unspecified impurities to the NMT 0.16% for Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension within 3 months following approval is proposed. Since the formulations of Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension are intended for generic substitution, they will not lead to an increased exposure to the environment. An environmental risk assessment is, therefore, not deemed necessary. From a non-clinical point of view, the approval of Linezolid 2 mg/ml Infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension can be granted provided that the applicant meets the post-approval commitments listed above. IV Clinical aspects IV.1 Introduction The applicant has not conducted any clinical studies with linezolid. Consent has been given by the existing marketing authorisation holders of the reference products, Zyvox 2 mg/ml Solution for Infusion (Pfizer Limited), Zyvox 100 mg/5 ml Granules for Oral Suspension (Pharmacia Limited) and Zyvox 600 mg Film-Coated Tablets (Pharmacia Limited), to use the data for these reference products in support of the current applications for Linezolid 2 mg/ml Infusion, Linezolid 600 mg Tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension. The applicant s clinical overview has been written by an appropriately qualified person and is considered acceptable. IV.2 Pharmacokinetics Linezolid 2 mg/ml infusion and are identical products and, therefore, have an identical formulation and manufacturing process, and the manufacturing sites for the finished dosage form are the same. All applicable clinical studies were previously evaluated for Zyvox 2 mg/ml Solution for Infusion and found to be acceptable. Bioequivalence studies are, therefore, not necessary. Linezolid 600 mg tablets and Zyvox 600 mg film-coated tablets are identical products and, therefore, have an identical formulation and manufacturing process, and the manufacturing sites for the finished dosage form are the same. All applicable clinical studies were previously evaluated for Zyvox 600 mg film-coated tablets and found to be acceptable. Bioequivalence studies are, therefore, not necessary. Linezolid 100 mg/5 ml Granules for Oral Suspension and Zyvox 100 mg/5 ml Granules for Oral Suspension are identical products and, therefore, have an identical formulation and manufacturing process, and the manufacturing sites for the finished dosage form are the same. All applicable clinical studies were previously evaluated for and Zyvox 100 mg/5 ml Granules for Oral Suspension and found to be acceptable. Bioequivalence studies are, therefore, not necessary. 12

13 IV.3 Pharmacodynamics No new pharmacodynamics 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 No new clinical safety data are required for these applications and none have been submitted. 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 Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension. A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, are listed below: Summary table of safety concerns 13

14 Planned risk minimisation activities V.7 Discussion on the clinical aspects The grant of marketing authorisations is recommended for these applications. V User consultation The applicant has confirmed that the layout and content of the package leaflet for each linezolid product is identical (with the exception of the product name) to that of the respective reference product. The package leaflet for the reference product Zyvox 100 mg/5 ml Granules for Oral Suspension 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, as amended. The language used for the purpose of user testing the PIL was English. The applicant included this user-testing study and two reports bridging Zyvox 2 mg/ml Solution for Infusion and Zyvox 500 mg film-coated tablets to the package leaflet for Zyvox 100 mg/5 ml Granules for Oral Suspension. 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. 14

15 VI Overall conclusion, benefit/risk assessment and recommendation The quality of Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension is acceptable, and no new non-clinical or clinical safety concerns have been identified. In the non-clinical documentation, there was no mention of the genotoxic potential of several drug substance impurities referred to in the quality section of the dossier. The applicant has been asked to meet the following post-approval commitments: - A commitment that additional testing should be provided, following approval, to determine the levels of potential genotoxic impurities are suitably controlled and either below the Threshold of Toxicological Concern (TTC) limit or suitably qualified. The applicant must complete this testing by the end of September If absence of any potentially genotoxic compound in the final drug substance or in an intermediate is claimed, this needs to be demonstrated by corresponding analytical results from at least 6 consecutive pilot batches or 3 consecutive production size batches. The analytical method used should be capable of detecting the analyte at least at half of the concentration corresponding to the TTC of the substance (or sum of substances, if the same alerting structure is contained in more than one substance). - A commitment to tighten the limit for unspecified impurities to the NMT 0.16% for Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension within 3 months following approval is proposed. The overall benefit/risk assessment is, therefore, considered to be positive. The Summaries of Product Characteristics (SmPCs), package leaflets 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 SmPC and package leaflets for these products are available on the MHRA website. The currently approved labels are listed below: 15

16 Labelling for Linezolid 2mg/ml Infusion PARTICULARS TO APPEAR ON THE OUTER PACKAGING PLASTIC BAG/OVERWRAP /SHIPPER (FREEFLEX) LABEL 1. NAME OF THE MEDICINAL PRODUCT Linezolid Pfizer 2mg/ml Solution for Infusion for use in Adults Linezolid PCO to complete 2. STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 2 mg linezolid. 300 ml infusion bags contain 600 mg linezolid. 3. LIST OF EXCIPIENTS Glucose monohydrate, Soduim Citrate (E331), Citric acid anhydrous (E330)and water for injection. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Solution for infusion [1 bag] [2 bags] [5 bags] [10 bags] [20 bags] [25 bags] [ ] Only for Shipper label 5. METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use. Read the package leaflet before use. 16

17 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP MM/YYYY 9. SPECIAL STORAGE CONDITIONS Store in the original package (overwrap and carton) until ready to use in order to protect from light. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused solution must be discarded 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{ }> 12. MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 13. BATCH NUMBER Batch No. 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 17

18 PCO to complete 15. INSTRUCTIONS ON USE Check for minute leaks by squeezing the bag firmly. If the bag leaks do not use. Do not use in series connections. Do not introduce any additives to this solution. Do not reconnect partailly used bags. 16. INFORMATION IN BRAILLE Not applicable 18

19 Labelling text for Linezolid 600 mg tablets PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/BOX 1. NAME OF THE MEDICINAL PRODUCT for use in Adults Linezolid PCO to complete 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 600mg Linezolid 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 10 film-coated tablets (Blister) 20 film-coated tablets (Blister) 30 film-coated tablets (Blister) 50 film-coated tablets (Blister) 60 film-coated tablets (Blister) 100 film-coated tablets (Blister) 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of sight and reach of children. 19

20 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXPIRY 9. SPECIAL STORAGE CONDITIONS 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{ }> 12. MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 13. BATCH NUMBER BATCH 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. PCO to complete 15. INSTRUCTIONS ON USE 20

21 16. INFORMATION IN BRAILLE PCO to complete MINIMUM PARTICULARS TO APPEAR ON BLISTERS FOIL 1. NAME OF THE MEDICINAL PRODUCT Linezolid Pfizer 600 mg film-coated Tablets for use in Adults Linezolid 2. NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer 3. EXPIRY DATE Exp 4. BATCH NUMBER Lot 5. OTHER 21

22 Labelling for Linezolid 100 mg/5 ml Granules for Oral Suspension PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1. NAME OF THE MEDICINAL PRODUCT for use in Adults Linezolid PCO to complete 2. STATEMENT OF ACTIVE SUBSTANCE(S) Following reconstitution, each 5 ml contains 100 mg linezolid 3. LIST OF EXCIPIENTS Also contains: Sucrose (210.6 mg/ml), fructose, sorbitol, mannitol, aspartame and sodium. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS 1 bottle (240 ml) with 66 g granules for oral suspension 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. Before use, gently invert the bottle a few times. DO NOT SHAKE. Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE Expiry Use within 21 days of reconstitution 22

23 9. SPECIAL STORAGE CONDITIONS Before reconstitution: Keep the bottle tightly closed. After reconstitution: Keep the bottle in the outer carton. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{ }> 12. MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 13. BATCH NUMBER Batch 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. PCO to complete 15. INSTRUCTIONS ON USE [PCO to complete] Linezolid Pfizer comes as granules which will be made up exclusively by the pharmacist to make a suspension for you to take Dispensing instructions: Loosen granules and add 123 ml water (in two equal portions) to give 150 ml oral suspension. Shake well between each addition of water. 16. INFORMATION IN BRAILLE 23

24 Linezolid Pfizer 100 mg/5 ml Suspension PCO complete PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL 1. NAME OF THE MEDICINAL PRODUCT for use in Adults Linezolid PCO to complete 2. STATEMENT OF ACTIVE SUBSTANCE(S) Following reconstitution, each 5 ml contains 100 mg linezolid 3. LIST OF EXCIPIENTS Also contains: Sucrose (210.6 mg/ml), fructose, sorbitol, mannitol, aspartame and sodium. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS 1 bottle (240 ml) with 66 g granules for oral suspension 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. Before use, gently invert the bottle a few times. DO NOT SHAKE. Read the package leaflet before use 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 24

25 8. EXPIRY DATE Expiry Use within 21 days of reconstitution 9. SPECIAL STORAGE CONDITIONS Before reconstitution: Keep the bottle tightly closed. After reconstitution: Keep the bottle in the outer carton. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{ }> 12. MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 13. BATCH NUMBER Batch 14. GENERAL CLASSIFICATION FOR SUPPLY PCO to Complete Medicinal product subject to medical prescription. 15. INSTRUCTIONS ON USE [PCO to Complete] Linezolid Pfizer comes as granules which will be made up exclusively by the pharmacist to make a suspension for you to take 25

26 Dispensing instructions: Loosen granules and add 123 ml water (in two equal portions) to give 150 ml oral suspension. Shake well between each addition of water. 16. INFORMATION IN BRAILLE PCO to Complete] 26

27 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 Assessment report attached Y/N (version) 27

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