Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - telithromycin - tablet, film coated - 400 mg

European Union - English - EMA (European Medicines Agency)

aventis pharma s.a. - telithromycin - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - 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 oldercommunity-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 oldertonsillitis / 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.

European Union - English - EMA (European Medicines Agency)

aventis pharma s.a. - telithromycin - community-acquired infections; pharyngitis; bronchitis, chronic; pneumonia; tonsillitis; sinusitis - 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 sinusitisin 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).

Canada - English - Health Canada

sanofi-aventis canada inc - telithromycin - tablet - 400mg - telithromycin 400mg - ketolides

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi - telithromycin - tablet - 400mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sanofi-aventis - telithromycin - tablet - 400 mg