🇪🇺 Ketek in European Union

EMA authorised Ketek on 9 July 2001

Marketing authorisations

Application: EMEA/H/C/000354
Marketing authorisation holder: Aventis Pharma S.A.
Local brand name: Ketek
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
Status: withdrawn

Application: EMEA/H/C/000355
Marketing authorisation holder: Aventis Pharma S.A.
Local brand name: Levviax
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 (s
Status: withdrawn

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Ketek approved in European Union?

Yes. EMA authorised it on 9 July 2001; EMA authorised it on 9 July 2001.

Who is the marketing authorisation holder for Ketek in European Union?

Aventis Pharma S.A. holds the EU marketing authorisation.