Galantamine Stada

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Galantamine Stada. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Galantamine Stada do not outweigh its risks, and the marketing authorisation cannot be granted in Austria or in other Member States of the EU: the Czech Republic, Denmark, Finland, Ireland, Portugal, Slovakia and Spain.

Key facts

Approved name
Galantamine Stada
International non-proprietary name (INN) or common name
galantamine
Associated names
  • Galantamina
  • Galantamine Tiefenbacher
  • Galantamina Ciclum
  • Galatnax xl
  • Galastad
Reference number
EMEA/H/A-29/001268
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
23/09/2010
EC decision date
21/02/2011

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:

How useful was this page?

Add your rating