The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
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Committee for Medicinal Products for Human Use (CHMP)
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A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.
The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.
Amglidia is a new formulation of glibenclamide, specifically developed for use in newborns, toddlers and children...
The EMA has recommended granting a marketing authorisation in the EU for Lamzede a long-term enzyme replacement therapy for alpha-mannosidosis...
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...