Levviax

Withdrawn

This medicine's authorisation has been withdrawn

telithromycin

Overview

On 9 July 2001 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Levviax 400 mg film coated tablets.

The marketing authorisation holder (MAH) responsible for Levviax is Aventis Pharma S.A. On 13 November 2007, the European Commission was notified by the MAH of its decision to voluntarily withdraw the marketing authorisation for Levviax for commercial reasons. Levviax was never marketed in the European Union. Ketek is an identical product available in the European Union. On 18 December 2007 the European Commission issued a decision to withdraw the marketing authorisation for Levviax. 

Pursuant to this decision the European Public Assessment Report for Levviax is updated to reflect that the marketing authorisation is no longer valid.

Levviax : EPAR - Summary for the public

Product information

Levviax : EPAR - Product Information

Levviax : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Levviax
• Active substance:
  telithromycin
• International non-proprietary name (INN) or common name:
  telithromycin
• Therapeutic area (MeSH):
  • Community-Acquired Infections
  • Pharyngitis
  • Bronchitis, Chronic
  • Pneumonia
  • Tonsillitis
  • Sinusitis
• Anatomical therapeutic chemical (ATC) code:
  J01FA15

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

When prescribing Levviax consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Levviax is indicated for the treatment of the following infections:
In patients of 18 years and older:
-Community-acquired pneumonia, mild or moderate (see section 4.4).
- 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 (see sections 4.4 and 5.1):
- 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 (see sections 4.4 and 5.1).

Authorisation details

• EMA product number:
  EMEA/H/C/000355
• 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:
  09/07/2001
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Levviax : EPAR - Procedural steps taken before authorisation

Levviax : EPAR - Scientific Discussion