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The marketing authorisation (MA) for Mabcampath has been withdrawn at the European level, on the initiative of the MA holder, Genzyme Europe BV, for commercial reasons. Mabcampath is a monoclonal antibody (alemtuzumab) used in some chronic lymphocytic leukaemia. Appropriate access to this medicine will be implemented in each Member State to ensure that patients who are currently benefiting from the treatment can continue.

An applicant for a parallel import authorisation of a medicine must now submit to the famhp the PIL draft accompanied by a form containing the information required by the regulation. This information no longer needs to be included in the PIL itself which must correspond to the latest version of the reference medicine leaflet. The PIL to which the completed form is attached on the first page shall, after approval, be attached to the parallel import authorisation.