Zeftera (previously Zevtera)
ceftobiprole
Table of contents
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) |
|
| 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
|