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.

Questions and answers on the recommendation for the refusal of the marketing authorisation for Zeftera

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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

Application details

EMA product number
EMEA/H/C/000883
Marketing authorisation applicant
Janssen-Cilag International NV
Opinion adopted
24/06/2010
Refusal of marketing authorisation
16/09/2010

Assessment history

Zeftera : EPAR - Public assessment report

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