Ketek

Withdrawn

This medicine's authorisation has been withdrawn

telithromycin

Overview

On 7 June 2019, the European Commission withdrew the marketing authorisation for Ketek (telithromycin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Aventis Pharma S.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Ketek was granted marketing authorisation in the EU on 9 July 2001 for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis caused by Streptococcus pyogenes. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period and then granted unlimited validity in 2011. The product had not been marketed in the EU since 1 July 2018. 

The European Public Assessment Report (EPAR) for Ketek is updated to indicate that the marketing authorisation is no longer valid.

Ketek : EPAR - Summary for the public

Product information

Ketek : EPAR - Product Information

Ketek : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ketek
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000354
• Marketing authorisation holder:
  Aventis Pharma S.A.

  20 avenue Raymond Aron; 92165 Antony Cedex; France

• Marketing authorisation issued:
  09/07/2001
• Withdrawal of marketing authorisation:
  07/06/2019
• Revision:
  25

Assessment history

Changes since initial authorisation of medicine

Ketek : EPAR - Procedural steps taken and scientific information after authorisation

Ketek-H-C-379-P46-0060 : EPAR - Assessment Report

Adopted Reference Number: EMA/743325/2014

Ketek-H-C-354-PSUV-0060 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/294682/2014

Ketek-H-C-354-A45-0039 : EPAR - Assessment Report

Adopted Reference Number: EMA/531185/2012

Ketek-H-C-354-A22-41: EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Ketek : EPAR - Procedural steps taken before authorisation

Ketek : EPAR - Scientific Discussion