Methylphenidate Hexal
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 25 July 2013, 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 Methylphenidate Hexal. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Hexal outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.
Key facts
Approved name |
Methylphenidate Hexal
|
International non-proprietary name (INN) or common name |
methylphenidate hydrochloride |
Class |
-
|
Reference number |
EMEA/H/A-29/1360
|
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. |
Status |
European Commission final decision
|
Opinion date |
25/07/2013
|
EC decision date |
09/10/2013
|
All documents
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Questions and answers on Methylphenidate Hexal (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) - Outcome of a procedure under Article 29 of Directive 2001/83/EC (PDF/66.21 KB)
First published: 26/07/2013
Last updated: 05/12/2013
EMEA/H/A-29/1360 -
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Methylphenidate Hexal Article-29 referral - Annex I (PDF/55.26 KB)
First published: 05/12/2013
Last updated: 05/12/2013 -
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Methylphenidate Hexal Article-29 referral - Annex II (PDF/60.36 KB)
First published: 05/12/2013
Last updated: 05/12/2013 -
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Methylphenidate Hexal Article-29 referral - Annex III (PDF/43.92 KB)
First published: 05/12/2013
Last updated: 05/12/2013 -
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Methylphenidate Hexal Article-29 referral - Assessment report (PDF/285.53 KB)
Adopted
First published: 05/12/2013
Last updated: 05/12/2013
EMA/596773/2013
Document description
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies