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Active Substance: telithromycin
Common Name: telithromycin
ATC Code: J01FA15
Marketing Authorisation Holder: Aventis Pharma S.A.
Active Substance: telithromycin
Status: Withdrawn
Authorisation Date: 2001-07-09
Therapeutic Area: Community-Acquired Infections Pneumonia Bronchitis, Chronic Sinusitis Tonsillitis Pharyngitis
Pharmacotherapeutic Group: Antibacterials for systemic use

Therapeutic 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 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).

The marketing authorisation for Levviax has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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