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Published on 19 March 2012

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Generic positive opinions for EU released

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The Committee for Medicinal Products for Human Use (CHMP) reached a positive opinion on generics of docetaxel and zoledronic acid at its March 2012 meeting. 

 

Docetaxel Accord and Docetaxel Kabi, marketed by Accord Healthcare Ltd and Fresenius Kabi Oncology Plc, are generic forms of Taxotere, which the EU authorised in 1995. 

 

The CHMP adopted a positive opinion of the two medicines for treatment of breast, prostate and non-small cell lung cancer, along with gastric adenocarcinoma and cancers of the head and neck.

 

Zoledronic acid, marketed by Teva Teva Pharma B.V., also received a positive opinion for treatment of osteoporosis in postmenopausal women and in men in whom the risk of fracture is raised. 

 

Also included in the positive opinion were treatment for osteoporosis associated with long-term systemic glucocorticoid therapy and adult treatment of Paget’s disease of the bone. 

 

The positive opinions were listed on a new, page format for the main opinions adopted at the March 2012 CHMP meeting. The previous format included two PDF documents. 

 

European Medicines Agency



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