Committee for Medicinal Products for Human Use


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Committee for Medicinal Products for Human Use

The European Medicines Agency's committee, which is responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.
References in periodicals archive ?
The meetings of the Committee for Medicinal Products for Human Use and the Informal Pharmacovigilance Risk Assessment Committee in Vilnius are two of the five scheduled meetings planned during Lithuanian Presidency of the EU Council, which are organised by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania.
Astellas Pharma Europe, a pharmaceutical company, has received a positive opinion recommending a variation to amend the marketing authorisation for enzalutamide from the European Medicines Agency's Committee for Medicinal Products for Human Use, it was reported yesterday.
M2 EQUITYBITES-March 3, 2015-European Medicines Agency's Committee for Medicinal Products for Human Use offers positive recommendation for Roche's Avastin
It is the first opioid to be granted a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.
M2 EQUITYBITES-December 2, 2014-Novartis receives accelerated assessment for LCZ696 from The European Medicines Agency's Committee for Medicinal Products for Human Use
Navidia Biopharmaceuticals Inc, a US-based biopharmaceutical company, has announced that its Lymphoseek 250 micrograms kit for radiopharmaceutical preparation has received recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for marketing authorisation in the European Union, it was reported on Friday.
The Committee for Medicinal Products for Human Use recommendation of OZURDEX is for diabetic macular edema patients who have an artificial lens implant, or who are considered otherwise unsuitable for non-corticosteroid therapy.
Both firms stated that they are committed to the Nerventra clinical development programme for multiple sclerosis and are concentrating on evaluating the Committee for Medicinal Products for Human Use's feedback to determine potential next steps.
Pharmaceutical company Teva Pharmaceutical Industries and Active Biotech (NASDAQ OMX NORDIC:ACTI) on Friday jointly announced the Committee for Medicinal Products for Human Use's (CHMP) opinion against the recommendation of NERVENTRA for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the EU.
The Committee for Medicinal Products for Human Use opinion was based on positive and consistent results from three pivotal phase III studies in patients with GT1 HCV; QUEST-1 and QUEST-2 in treatment-naive patients and PROMISE in patients (who have relapsed after previous interferon-based therapy).
The Committee for Medicinal Products for Human Use's decision has reportedly established a path forward for a final approval decision from the European Commission that is expected in the next few months.
BioMarin Pharmaceutical, a United States-based pharmaceutical company, has received positive opinion for the marketing authorisation application for its drug, Vimizim (elosulfase alfa), from the European Medicines Agency's Committee for Medicinal Products for Human Use, it was reported on Friday.
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