Public Assessment Report - GOV.UK

1 Public Assessment Report Decentralised Procedure Copaxone 40 mg/ml Solution for Injection, Pre- filled Syringe (Glatiramer acetate) Procedure No: UK/H/0453/004/DC UK Licence No: PL 10921/0026 Teva Pharmaceuticals Limited Copaxone 40 mg/ml Solution for Injection, Pr e- filled Syr inge UK/H/0453/004/DC 2 Lay Summary Copaxone 40 mg/ml Solution for Injection, Pre- filled Syringe (glatiramer acetate) This is a summary of the Public Assessment Report (PAR) for Copaxone 40 mg/ml Solution for Injection, Pre- filled Syringe (PL 10921/0026; UK/H/0453/004/DC).

2 Copaxone 40 mg/ml Solution for Injection, Pre- filled Syringe will be referred to as Copaxone 40 mg/ml Injection throughout this PAR, for ease of reading. The PAR explains how Copaxone 40 mg/ml Injection w as assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Copaxone 40 mg/ml Injection. For practical information about using Copaxone 40 mg/ml Injection, patients should read the package leaflet or contact their doctor or pharmacist. What is Copaxone 40 mg/ml Injection and what is it used for?

3 Copaxone 40 mg/ml Injection is used to treat multiple sclerosis (MS), whereby it reduces the number of times that a patient with MS suffers attacks/relapses. Copaxone is not, however, used to treat any form of MS that does not have relapses, or hardly any relapses. Copaxone 40 mg/ml Injection contains the active substance glatiramer acetate. This active substance is classed as an immunomodulating agent, which means that it modifies the way in which the body s immune system works. How does Copaxone 40 mg/ml Injection work? The mechanism by which glatiramer acetate works is not fully understood but it is thought that it modifies the immune response within the body that causes the symptoms of MS.

4 How is Copaxone 40 mg/ml Injection used? The pharmaceutical form of Copaxone 40 mg/ml Injection is a solution for injection, presented in a pre- filled syringe. It is very important to inject Copaxone 40 mg/ml Injection properly. The first time you use Copaxone 40 mg/ml Injection you will be given full instructions and will be supervised by a doctor or nurse. They will be with you while you give yourself the injection and for half an hour afterwards, just to make sure you do not have any problems. Please read Section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment.

5 The usual dose in adults is one pre- filled syringe (40 mg of glatiramer acetate), administered under the skin (subcutaneously), three times a week. The doses should be injected at least 48 hours apart, for example Monday, Wednesday and Friday. It is recommended to administer Copaxone 40 mg/ml Injection on the same days every week. The medicine can only be obtained with a prescription. What benefits of Copaxone 40 mg/ml Injection have been shown in studies? The company provided its own data on efficacy and safety studies. These studies have shown that Copaxone 40 mg/ml Injection is effective in treating relapsing forms of MS.

6 Copaxone 40 mg/ml Solution for Injection, Pr e- filled Syr inge UK/H/0453/004/DC 3 What are the possible side effects from Copaxone 40 mg/ml Injection? Like all medicines, this medicine can cause side effects although not everybody gets them. For information about side effects that may occur with using Copaxone 40 mg/ml Injection, please refer to the package leaflet or the Summary of Product Characteristics (SmPC) available on the Medicines and Healthcare products Regulatory Agency website. Why is Copaxone 40 mg/ml Injection approved?

7 The view was that the benefits of Copaxone 40 mg/ml Injection outweigh the identified risks and it was recommended that this product be approved for use. What measures are being taken to ensure the safe and effective use of Copaxone 40 mg/ml Injection? A Risk Management Plan (RMP) has been developed to ensure that Copaxone 40 mg/ml Injection is used as safely as possible. Based on this plan, safety information has been included in the SmPC and the package leaflet for this product, including the appropriate precautions to be followed by healthcare professionals and patients.

8 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 Copaxone 40 mg/ml Injection Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and the UK agreed to grant a marketing authorisation for Copaxone 40 mg/ml Injection on 04 December 2014.

9 The marketing authorisation in the UK was granted on 08 January 2015. The full PAR for Copaxone 40 mg/ml Injection follows this summary. For more information about treatment with Copaxone 40 mg/ml Injection, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in April 2017. Copaxone 40 mg/ml Solution for Injection, Pr e- filled Syr inge UK/H/0453/004/DC 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 22 VI Overall conclusion, benefit/risk Assessment and recommendation Page 22 Table of content of the PAR update for MRP and DCP Page 27 Copaxone 40 mg/ml Solution for Injection.

10 Pr e- filled Syr inge UK/H/0453/004/DC 5 I Introduction Based on the review of the data on quality, safety and efficacy, the Member States agreed to grant a marketing authorisation (MA) for the medicinal product Copaxone 40 mg/ml Injection. This application was submitted using the Decentralised Procedure (DCP) with t he UK as Reference Member State (RMS) and Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and Sweden as Concerned Member States (CMSs).