Tag Archives: Committee for Medicinal Products for Human Use

Sandoz: EMA Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for marketing authorization of infliximab

Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release

AstraZeneca announces positive CHMP opinion recommending the approval of new antibiotic, CAZ AVI

LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release

EMA’s view on coated nanomedicines general issues published

16-8-2013 — /EuropaWire/ — The European Medicines Agency has published a reflection paper on general issues for consideration regarding the parenteral administration of coated nanomedicines today. The reflection paper describes general issues to consider during the development of nanomedicines that have a coating, including: the effect … Read the full press release