Valebo and associated names

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

Overview

On 19 December 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 Valebo. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Valebo outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom.

Key facts

Approved name
Valebo and associated names
International non-proprietary name (INN) or common name
alendronic acid and alfacalcidol
Associated names
  • Tevabone
  • Teboneva
Reference number
EMEA/H/A-29/1364
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
19/12/2013
EC decision date
10/03/2014

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:

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