Pending EC decision: Masiviera, masitinib, Opinion date: 23-Jan-2014

AB Science has requested a re-examination of Masiviera after the CHMP’s January 2014 opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation (External Source EMA, AB Science, FEB 21, 2014, View Source [SID:1234500129]). On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masiviera, intended for the treatment of advanced inoperable pancreatic cancer.