Oasmia Gets Positive Opinion for Apealea(R) (paclitaxel micellar) in EU

Apealea receives positive CHMP opinion in the European Union for treatment of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in combination with carboplatin in first relapse

Uppsala, Sweden, September 21, 2018 – Oasmia Pharmaceutical ABOASM, +22.98% today announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Apealea in combination with carboplatin for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The CHMP considers that the product Apealea in combination with carboplatin has a positive benefit-risk balance and is considered approvable for the above-mentioned indication.

The CHMP’s positive opinion will now be considered by the European Commission. If the CHMP opinion is affirmed, the European Commission will grant a centralized marketing authorization with unified labelling that is valid in 28 countries of the European Union (EU), as well as the European Economic Area members, Iceland, Lichtenstein and Norway.

https://www.marketwatch.com/press-release/oasmia-pharmaceutical-receives-positive-chmp-opinion-for-apealear-paclitaxel-micellar-in-the-european-union-2018-09-21