Ketek

RSS

telithromycin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ketek has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 19/06/2019

Authorisation details

Product details
Name
Ketek
Agency product number
EMEA/H/C/000354
Active substance
telithromycin
International non-proprietary name (INN) or common name
telithromycin
Therapeutic area (MeSH)
  • Sinusitis
  • Tonsillitis
  • Bronchitis, Chronic
  • Pharyngitis
  • Community-Acquired Infections
  • Pneumonia, Bacterial
Anatomical therapeutic chemical (ATC) code
J01FA15
Publication details
Marketing-authorisation holder
Aventis Pharma S.A.
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
09/07/2001
Contact address
20 avenue Raymond Aron
92165 Antony Cedex
France

Product information

07/02/2017 Ketek - EMEA/H/C/000354 - N/0068

Contents

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Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance.

Ketek is indicated for the treatment of the following infections:

In patients of 18 years and older

  • community-acquired pneumonia, mild or moderate.
  • when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin:
    • acute exacerbation of chronic bronchitis;
    • acute sinusitis;

In patients of 12 years and older

  • tonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA.

Assessment history

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