Ketek : EPAR - Summary for the public (PDF/525.39 KB)
First published: 06/02/2008
Last updated: 19/06/2019
|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||
07/02/2017 Ketek - EMEA/H/C/000354 - N/0068
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Antibacterials for systemic use
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.