Moxifloxacin

Current status:
European Commission final decision

Overview

The European Medicines Agency (EMEA) has completed a review of new data on the safety of oral formulations (taken by mouth) of moxifloxacin-containing medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of these medicines for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia continue to outweigh their risks, but their use should be restricted. The review was carried out under an 'Article 107' procedure1.


1 Article 107 of Directive 2001/83/EC as amended.

Key facts

Approved name
Moxifloxacin
International non-proprietary name (INN) or common name
moxifloxacin
Associated names
  • Avalox
  • Avelox
Reference number
CHMP/380454/08
Type
Article 107 procedures (prior to July 2012)

This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. This procedure has been replaced by Article 107i.

Status
European Commission final decision
Opinion date
24/07/2008
EC decision date
24/10/2008

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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