Regulatory/GMP Compliance, Europe

CHMP Adopts Positive Opinion for Dapivirine Vaginal Ring

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The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) for women in non-European Union countries where HIV disease burden is high. According to a July 24, 2020 press release, this reco

EC Grants Marketing Authorization for Remsima

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Celltrion Healthcare has announced in a July 27, 2020 press release, that the European Commission (EC) has granted marketing authorization for its subcutaneous (SC) formulation of Remsima (infliximab, CT-P13). Remsima SC is now approved for the treatment of adult patients with ankylosing s