European Medicines Agency

EUROPEAN MEDICINES AGENCY NEWSROOM (164 press releases)

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ZALTRAP® (aflibercept) Receives CHMP Positive Opinion in the European Union for Previously Treated Metastatic Colorectal Cancer

PRESS RELEASE -- 19, November 2012

Paris, France and Tarrytown, NY, 19-11-2012 — /europawire.eu/ — Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion … Read the full press release

European Medicines Agency starts infringement procedure to investigate Roche’s alleged non-compliance with pharmacovigilance obligations

PRESS RELEASE -- 25, October 2012

25-10-2012 — /europawire.eu/ — The European Medicines Agency has started an infringement procedure against Roche Registration Ltd, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its … Read the full press release

European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density

PRESS RELEASE -- 23, October 2012

23-10-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Amyvid (florbetapir 18F) as a diagnostic agent in patients who are being evaluated for Alzheimer’s disease (AD) and other causes of … Read the full press release

European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU

PRESS RELEASE -- 23, October 2012

London, 23-10-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a recommendation to give marketing authorisation to insulin degludec, a new basal analogue insulin for the treatment of diabetes mellitus in adults. It … Read the full press release