Levothyroxine Alapis
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 18 October 2012, 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 Levothyroxine Alapis. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and the marketing authorisation cannot be granted in the Netherlands or in the following EU Member States: Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom.
Key facts
Approved name |
Levothyroxine Alapis
|
International non-proprietary name (INN) or common name |
levothyroxine sodium |
Class |
-
|
Reference number |
EMEA/H/A-29/1328
|
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 |
18/10/2012
|
EC decision date |
14/01/2013
|
All documents
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Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) (PDF/79.51 KB)
First published: 19/10/2012
Last updated: 15/02/2013
EMA/659681/2012 Rev.1 -
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List item
Levothyroxine Alapis- Article 29 referral - Assessment report (PDF/128.8 KB)
Adopted
First published: 15/02/2013
Last updated: 15/02/2013
EMA/701628/2012 -
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Levothyroxine Alapis - Article 29(4) referral - Annex I (PDF/57.37 KB)
First published: 15/02/2013
Last updated: 15/02/2013 -
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Levothyroxine Alapis - Article 29(4) referral - Annex II (PDF/44.31 KB)
First published: 15/02/2013
Last updated: 15/02/2013 -
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