CHMP positive for Onivyde pegylated liposomal + chemotherapy for metastatic adenocarcinoma of the pancreas,- Servier
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal. The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.
The CHMP adopted a new indication as follows: Onivyde pegylated liposomal is indicated: in combination with oxaliplatin, 5?fluorouracil (5?FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
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