Public Assessment Report Decentralised Procedure

1 Public Assessment Report Decentralised Procedure dexamethasone MG/ML SOLUTION FOR. INJECTION. ( dexamethasone sodium phosphate). Procedure No: UK/H/5163/001/DC. UK Licence No: PL 28176/0115. Strides Arcolab International Limited PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC. LAY SUMMARY. dexamethasone mg/ml Solution for Injection ( dexamethasone sodium phosphate). This is a summary of the Public Assessment Report (PAR) for dexamethasone mg/ml Solution for Injection (PL 28176/0115). It explains how dexamethasone mg/ml Solution for Injection was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use dexamethasone mg/ml Solution for Injection. For practical information about using dexamethasone mg/ml Solution for Injection, patients should read the package leaflet or contact their doctor or pharmacist. What is dexamethasone mg/ml Solution for Injection and what is it used for?

2 dexamethasone mg/ml Solution for Injection is a generic medicine'. This means that dexamethasone mg/ml Solution for Injection is similar to a reference medicine' already authorised in the European Union (EU) called Decadron mg/ml Solution for Injection. It is used in the treatment of acute conditions in which oral steroid treatment is not possible, such as: Shock ( after an accident, after surgery or due to blood poisoning). Swelling of the brain because of a brain tumour. Diseases of joints and soft tissues, such as rheumatoid arthritis. Allergic reactions. These conditions often require the use of other medicines in addition to dexamethasone mg/ml Solution for Injection. How is dexamethasone mg/ml Solution for Injection used? This medicine can only be obtained with a prescription. This medicine may be given intravenously (injection into a vein), intramuscularly (injection into a muscle) or directly into a joint or soft tissue.

3 This medicine may also be diluted with dextrose or sodium chloride solution and given as a slow injection via a drip into a vein (infusion). The dose of medicine given will depend upon the patient's age and medical condition and will be carefully adjusted by a doctor. Treatment with dexamethasone Solution for Injection is unlikely to be continued for more than a week or two, unless it is used for treatment of arthritic joints, when treatment may carry on for longer. If dexamethasone treatment needs to continue, tablets may be given rather than an injection. How does dexamethasone mg/ml Solution for Injection work? This medicine contains the active substance dexamethasone sodium phosphate, which belongs to a group of medicines called glucocorticoids (steroids). Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as dexamethasone ) is an effective way to treat various illnesses involving inflammation in the body.

4 dexamethasone reduces this inflammation, which could otherwise go on making your condition worse. How has dexamethasone mg/ml Solution for Injection been studied? The company provided data from the published literature on dexamethasone sodium phosphate. No additional studies were needed as dexamethasone mg/ml Solution for Injection is a generic 2. PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC. medicine that is given by injection and contains the same active substance as the reference medicine, Decadron mg/ml Solution for Injection. What are the benefits and risks of dexamethasone mg/ml Solution for Injection? Because dexamethasone mg/ml Solution for Injection is a generic medicine and is comparable to the reference medicine, its benefits and risks are taken as being the same as the reference medicine. Why is dexamethasone mg/ml Solution for Injection approved? It was concluded that, in accordance with EU requirements, dexamethasone mg/ml Solution for Injection has been shown to have comparable quality and to be comparable to Decadron mg/ml Solution for Injection.

5 Therefore, the view was that, as for Decadron mg/ml Solution for Injection, the benefit outweighs the identified risks. What measures are being taken to ensure the safe and effective use of dexamethasone mg/ml Solution for Injection? Safety information has been included in the summary of product characteristics and the package leaflet for dexamethasone mg/ml Solution for Injection, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about dexamethasone mg/ml Solution for Injection Spain, Norway and the UK agreed to grant Marketing Authorisations for dexamethasone mg/ml Solution for Injection (PL 28176/0115) on 25 November 2013. A Marketing Authorisation was granted in the UK on 24 December 2013. The full PAR for dexamethasone mg/ml Solution for Injection follows this summary. For more information about treatment with dexamethasone mg/ml Solution for Injection read the package leaflet or contact your doctor or pharmacist.

6 This summary was last updated in February 2014. 3. PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC. TABLE OF CONTENTS. Module 1: Information about initial Procedure Page 5. Module 2: Summary of Product Characteristics Page 6. Module 3: Patient Information Leaflet Page 7. Module 4: Labelling Page 8. Module 5: Scientific discussion during initial Procedure Page 9. I Introduction II About the product III Scientific overview and discussion Quality aspects Non-clinical aspects Clinical aspects IV Overall conclusion and benefit-risk Assessment Module 6: Steps taken after initial Procedure Page 15. 4. PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC. Module 1. Information about initial Procedure Product Name dexamethasone mg/ml Solution for Injection Type of Application Generic, Article 10(1). Active Substances dexamethasone sodium phosphate Form Solution for injection Strength mg/ml ( mg/ml of dexamethasone sodium phosphate equivalent to mg/ml of dexamethasone base).

7 MA Holder Strides Arcolab International Limited Unit 4, Metro Centre Tolpits Lane, Watford, Hertfordshire WD18 9SS. United Kingdom Reference Member State (RMS) UK. Concerned Member States (CMS) Spain and Norway Procedure Number UK/H/5163/001/DC. Timetable Day 210 25 November 2013. 5. PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC. Module 2. Summary of Product Characteristics In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) for products that have been granted Marketing Authorisations at a national level are available on the MHRA. website. 6. PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC. Module 3. Patient Information Leaflet In accordance with Directive 2010/84/EU the Patient Information Leaflets for products that are granted Marketing Authorisations at a national level are available on the MHRA website. 7. PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC.

8 Module 4. Labelling Carton: Label: 8. PAR dexamethasone mg/ml Solution for Injection UK/H/5163/001/DC. 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 application for dexamethasone mg/ml Solution for Injection (PL 28176/0115; UK/H/5163/001/DC). could be approved. The application was submitted via the Decentralised Procedure , with the UK as Reference Member State (RMS), and Spain and Norway as Concerned Member States (CMS). This product is a prescription-only medicine (legal classification POM). This was an application made under the Decentralised Procedure (DCP), according to Article 10(1) of Directive 2001/83/EC, as amended, claiming to be a generic medicinal product of Decadron mg/ml Solution for Injection (Merck Sharp & Dohme Limited), which was initially granted a marketing authorisation in the UK on 31 July 1987.

9 dexamethasone Solution for Injection is indicated in acute conditions in which oral glucocorticoid therapy is not feasible such as: Shock: of haemorrhagic, traumatic, surgical or septic origin; cerebral oedema associated with cerebral neoplasm; inflammatory diseases of joints and soft tissue such as rheumatoid arthritis. Short term management of acute self-limited allergic conditions such as angioneurotic oedema or acute exacerbations of chronic allergic disorders such as bronchial asthma or serum sickness. High doses of dexamethasone are intended for the adjunctive treatment of shock where massive doses of corticosteroids are needed. There is a lack of evidence that use of corticosteroids in septic shock affects mortality in the long term. Use must be accompanied by the appropriate concomitant systemic antibiotic treatment and supportive measures which the patient's condition may require. This product contains the active substance dexamethasone sodium phosphate.

10 dexamethasone sodium phosphate is a glucocorticosteroid which has anti-inflammatory and immunosuppressant activities. No new clinical or non-clinical studies were conducted, which is acceptable given that the application was based on being a generic medicinal product of an originator product that has been licensed for over 10 years. In accordance with the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 **), bioequivalence studies are not required for this type of product and none were submitted. The RMS has been assured that acceptable standards of Good Manufacturing Practice are in place for this product type at all sites responsible for the manufacture, assembly and batch release of this product. The RMS and CMS considered that the application could be approved at the end of Procedure on 25. November 2013. After a subsequent national phase, a licence was granted in the UK on 24 December 2013.