Octegra

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

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 Octegra solution for infusion. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Octegra solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely France and Portugal. However, the prescribing information for Octegra solution for infusion should be amended in all the Member States where it is authorised.

The review was carried out under an 'Article 29' referral1.

A European Commission decision on this opinion will be issued in due course.

1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

Key facts

Approved name
Octegra
International non-proprietary name (INN) or common name
moxifloxacin
Reference number
CHMP/150525/2009
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
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
19/03/2009
EC decision date
02/10/2009

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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