Request For Re-Examination Of Ceftobiprole Submitted To CHMP

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Dermatology
Article Date: 11 Mar 2010 - 13:00 PST

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Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that the Applicant Janssen-Cilag International NV (Janssen- Cilag), a Johnson & Johnson company, has submitted a request for re-examination of the negative opinion by the European Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI).

On February 18, 2010, the CHMP adopted a negative opinion on the MAA for ceftobiprole for the treatment of cSSTI. The Applicant Janssen-Cilag has given written notice to the Agency that it requests a re-examination of the negative opinion under standard procedures. According to current CHMP guidelines, a final opinion on the re-examination could be issued by the Agency within four to five months.

Source
Basilea Pharmaceutica Ltd.