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Levviax (telithromycin)

Region

🇪🇺 EU

Active substance

telithromycin

Company

Aventis Pharma S.A.

Status

Withdrawn

Therapeutic area

Community-Acquired Infections; Pharyngitis; Bronchitis, Chronic; Pneumonia; Tonsillitis; Sinusitis

EU approval

Mon 09 Jul 2001

Application

EMEA/H/C/000355

ATC

J01FA15

Official record

www.ema.europa.eu

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 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).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Ketek Withdrawn · Aventis Pharma S.A.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.