Levviax

RSS

telithromycin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Levviax has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/02/2008

Authorisation details

Product details
Name
Levviax
Agency product number
EMEA/H/C/000355
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
Publication details
Marketing-authorisation holder
Aventis Pharma S.A.
Revision
10
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

31/05/2007 Levviax - EMEA/H/C/000355 - A22/41

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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).

Assessment history

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