Zeftera (previously Zevtera)

Refused

This medicine has been refused authorisation

ceftobiprole

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

Adopted Reference Number: EMA/404483/2010

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

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