The marketing authorisation for Levviax has been withdrawn at the request of the marketing authorisation holder.
Levviax : EPAR - Summary for the public (PDF/351.7 KB)
First published: 15/02/2008
Last updated: 15/02/2008
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Aventis Pharma S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
20 avenue Raymond Aron
92165 Antony Cedex
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.
Antibacterials for systemic use
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).