The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
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Committee for Medicinal Products for Human Use (CHMP)
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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...
26 April 2017 | By Niamh Marriott, Junior Editor
CHMP has adopted a positive opinion for the company's MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease...
25 April 2017 | By Niamh Marriott, Junior Editor
The Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz's (a Novartis division) biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
2 March 2017 | By Niamh Marriott, Digital Editor
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for Abbvie’s shorter, eight-week treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) as an option for previously untreated adult patients with geotype 1b chronic hepatitis C virus (HCV)…
28 February 2017 | By Niamh Marriott, Digital Editor
If approved by the European Commission, daratumumab can be used for the treatment of adult patients with multiple myeloma...