Ketek
Withdrawn
This medicine's authorisation has been withdrawn
telithromycin
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 7 June 2019, the European Commission withdrew the marketing authorisation for Ketek (telithromycin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Aventis Pharma S.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Ketek was granted marketing authorisation in the EU on 9 July 2001 for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis caused by Streptococcus pyogenes. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period and then granted unlimited validity in 2011. The product had not been marketed in the EU since 1 July 2018.
The European Public Assessment Report (EPAR) for Ketek is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0068
07/02/2017
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ketek
- Active substance
- telithromycin
- International non-proprietary name (INN) or common name
- telithromycin
- Therapeutic area (MeSH)
- Sinusitis
- Tonsillitis
- Bronchitis, Chronic
- Pharyngitis
- Community-Acquired Infections
- Pneumonia, Bacterial
- Anatomical therapeutic chemical (ATC) code
- J01FA15
Pharmacotherapeutic group
Antibacterials for systemic useTherapeutic 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 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.
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