EMEA adopted positive opinion for vinflunine intended for the treatment of carcinoma of urothelial tract
Extended indication for bevacizumab in combination therapy with docetaxel to the first-line treatment of metastatic breast cancer
At the June, 2009 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion, recommending the granting of a marketing authorisation, for the following medicines:
- vinflunine ditartrate, from Pierre Fabre Medicament, intended for the treatment of carcinoma of urothelial tract. The review began on 27 February 2008, with an active review time of 196 days.
The Committee also adopted positive opinion for the following generic medicine, for which a reference medicine is already authorised in the European Union:
- topotecan hydrochloride, from Teva Pharma B.V., a generic of Hycamtin®, intended for the treatment of ovary carcinoma, small cell lung cancer and carcinoma of the cervix.
The Committee gave positive opinion for application for the extension of indication, adding new treatment options, for the following medicine:
- bevacizumab, from Roche Registration Ltd., to extend the indication to add combination therapy with docetaxel chemotherapy to the first-line treatment of metastatic breast cancer. Bevacizumab is already authorised in this indication in combination with paclixatel. It is also authorised for first-line combination therapy of patients with certain types of cancer of the colon or rectum, the kidney and non-small cell lung cancer.
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