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
English (EN)
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Deutsch (DE)
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ελληνικά (EL)
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français (FR)
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latviešu valoda (LV)
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Malti (MT)
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Nederlands (NL)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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Suomi (FI)
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svenska (SV)
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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
Assessment history
Zeftera : EPAR - Public assessment report
English (EN)
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