Zeftera (previously Zevtera)

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ceftobiprole

Refused
This medicine was refused authorisation for use in the European Union.

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.

This EPAR was last updated on 22/09/2010

Application details

Product details
Name
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
Application details
Marketing-authorisation applicant
Janssen-Cilag International NV
Date of opinion
24/06/2010
Date of refusal of marketing authorisation
16/09/2010

Assessment history

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