Overview
On 18 February 2010, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Zeftera, intended for treatment of complicated skin and soft-tissue infections in adults. The company that applied for authorisation is Janssen-Cilag International N.V. The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 24 June 2010.
Product details
- Name of medicine
- Zeftera (previously Zevtera)
- Active substance
- ceftobiprole medocaril
- International non-proprietary name (INN) or common name
- ceftobiprole
- Therapeutic area (MeSH)
- Skin Diseases, Infectious
- Soft Tissue Infections
- Anatomical therapeutic chemical (ATC) code
- J01DI01
Assessment history
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