Norditropin

Current status:
European Commission final decision

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
  • Norditropin FlexPro
  • Norditropin NordiFlex
  • Norditropin SimpleXx
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

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

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