Diclofenac epolamine 50 mg tablets
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 21 July 2016, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine diclofenac epolamine (50 mg tablets). The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of this product do not outweigh its risks, and the marketing authorisation cannot be granted in the United Kingdom (UK) or in the following Member States of the EU: Czech Republic, France and Slovakia.
Key facts
|
About this medicine
|
|
|---|---|
| Approved name |
Diclofenac epolamine 50 mg tablets
|
| International non-proprietary name (INN) or common name |
diclofenac
|
|
About this procedure
|
|
|---|---|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/H/A-29/1434
|
| Type |
Article 29(4) referrals
This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health. |
|
Key dates and outcomes
|
|
|---|---|
| CHMP opinion date |
25/02/2016
|
| EC decision date |
22/09/2016
|
All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Diclofenac Article-29 referral - Assessment report (PDF/157.85 KB)
First published: 10/10/2016
Last updated: 10/10/2016
EMA/629122/2016
Diclofenac Article-29 referral - Annex I (PDF/30.32 KB)
First published: 10/10/2016
Last updated: 10/10/2016
Diclofenac Article-29 referral - Annex II (PDF/49.16 KB)
First published: 10/10/2016
Last updated: 10/10/2016
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.