PRAC

Showing 4 posts of 4 posts found.

EMA review confirms risks of Abbvie and Biogen’s Zinbryta outweigh benefits

May 21, 2018
Research and Development, Sales and Marketing EMA, Europe, European Commission, PRAC, multiple sclerosis, pharma, zinbryta

The EMA has judged that the benefits offered by Zinbryta (daclizumab), Abbvie and Biogen’s humanised IgG1 monoclonal antibody for the …

EMA concludes HPV vaccines do not cause CRPS or POTS

November 9, 2015
Sales and Marketing EMA, HPV, HPV vaccine, PRAC, complex regional pain syndrome, drug safety, postural orthostatic tachycardia syndrome

The European Medicines Agency says there is no evidence from a detailed scientific review of reports linking complex regional pain …

EMA keeps Ariad cancer drug on the market

October 13, 2014
Sales and Marketing Ariad, CML, EMA, PRAC, iclusig, leukaemia, ponatinib

The EMA has recommended Ariad’s leukaemia drug Iclusig (ponatinib) should continue to be used under its current indication despite ongoing …

EMA starts contraceptive safety review

January 30, 2013
Manufacturing and Production, Sales and Marketing EMA, PRAC, VTE, contraception

Europe’s health regulator is to examine the safety of newer forms of contraceptive pills following concerns over potential health risks …

The Gateway to Local Adoption Series

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