Norditropin
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new indication for use in children with Prader-Willi syndrome. The Committee concluded that the change to the marketing authorisation cannot be granted.
Key facts
Approved name |
Norditropin
|
International non-proprietary name (INN) or common name |
somatropin |
Associated names |
|
Reference number |
EMEA/H/A-13/1304
|
Type |
Article 13 referrals
This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health. |
Status |
European Commission final decision
|
Opinion date |
15/12/2011
|
EC decision date |
06/03/2012
|
All documents
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Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) (PDF/57.76 KB)
Adopted
First published: 16/12/2011
Last updated: 19/04/2012
EMA/CHMP/966954/2011 -
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Norditropin - Article 13 referral - Assessment Report (PDF/96.56 KB)
First published: 19/04/2012
Last updated: 19/04/2012
EMA/171189/2012 -
List item
Norditropin - Article 13 referral - Annex I (PDF/646.85 KB)
First published: 19/04/2012
Last updated: 19/04/2012 -
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List item
Norditropin - Article 13 referral - Annex II (PDF/79.88 KB)
First published: 19/04/2012
Last updated: 19/04/2012 -
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