European Medicines Agency

Pivotal data showed Jetrea significantly resolved vitreomacular traction (VMT) and macular hole compared to placebo at day 28 (p<0.001)[1] Current standard of care for VMT is surgery or “watchful waiting” associated with further visual impairment that can lead to central … Read the full press release →

15-1-2013 — /europawire.eu/ — The European Medicines Agency has been formally notified by FGK Representative Service GmbH of its decision to withdraw its application for centralised marketing authorisation for the medicine Memantine FGK (memantine), 7 mg, 14 mg, 21 mg and … Read the full press release →

14-1-2013 — /europawire.eu/ — The European Medicines Agency is issuing this update in response to growing media reports about combined contraceptives and venous thromboembolism (blood clots in veins). It is well-established that combined contraceptives carry a very rare risk of blood … Read the full press release →

28-12-2012 — /europawire.eu/ — The European Medicines Agency has been formally notified by Only For Children Pharmaceuticals of its decision to withdraw its application for a centralised marketing authorisation for the medicine Loulla (mercaptopurine), 10 mg/ml, tablets and solution for oral … Read the full press release →

Agency issues interim advice 27-12-2012 — /europawire.eu/ — The European Medicines Agency has started a review of the safety and efficacy of Tredaptive, Pelzont and Trevaclyn, identical medicines that are used to treat adults with dyslipidaemia (abnormally high levels of fat … Read the full press release →

Turku, 18-12-2012 — /europawire.eu/ — Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization of Selincro(TM) (nalmefene; an … Read the full press release →

18-12-2012 — /europawire.eu/ — Biotie today reported top-line data from a Phase 2b study evaluating its adenosine A2a antagonist tozadenant (SYN115) in Parkinson’s disease (PD) patients experiencing levodopa related end of dose wearing off. The study met its primary endpoint of … Read the full press release →

CVMP opinions on veterinary medicinal products  14-12-2012 — /europawire.eu/ — The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for: Semintra (telmisartan), from Boehringer Ingelheim Vetmedica GmbH, for chronic kidney disease in cats. The Committee adopted … Read the full press release →

Selincro offers treatment in conjunction with psychosocial support 14-12-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Selincro, a medicinal product intended for the reduction … Read the full press release →

Updated advice to reduce risk of gas embolism during spray application 14-12-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of new instructions for healthcare professionals using the fibrin sealants … Read the full press release →

Agency invites expressions of interest for advisory groups 7-12-2012 — /europawire.eu/ — The European Medicines Agency today published a report highlighting the outcomes of the workshop on access to clinical-trial data and transparency which was hosted at the Agency on 22 November 2012. … Read the full press release →

4-12-2012 — /europawire.eu/ — The European Medicines Agency has been formally notified by Merck Sharp and Dohme Ltd. of its decision to withdraw its application for a centralised marketing authorisation for the medicine Jenzyl (ridaforolimus), 10-mg tablets. Jenzyl was intended to … Read the full press release →

28-11-2012 — /europawire.eu/ — The European Medicines Agency has been formally notified by Marvel LifeScience Ltd of its decision to withdraw its applications for centralised marketing authorisations for the medicines Solumarv, Isomarv and Combimarv (human insulin), all 100 international units (IU)/ml … Read the full press release →

26-11-2012 — /europawire.eu/ — “The European Medicines Agency is committed to proactive publication of clinical-trial data, once the marketing-authorisation process has ended. We are not here to decide if we publish clinical-trial data, but how.” This is how Guido Rasi, Executive Director … Read the full press release →

New measures to minimise the risk of gas embolism during spray application 20-11-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of risk-minimisation measures for the fibrin sealants Evicel and Quixil … Read the full press release →

Brussels, 20-11-2012 — /europawire.eu/ — The European Antibiotic Awareness Day is an annual European public health initiative that takes place on 18 November. Ahead of this event, the European Centre for Disease Control (ECDC) today released the latest data on antibiotic resistance and consumption in the … Read the full press release →

Diabetes portfolio poised to significantly expand in 2013 to meet patient needs Paris, France, 20-11-2012 — /europawire.eu/ —  Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) … Read the full press release →

Lisbon, 20-11-2012 — /europawire.eu/ — Europe is faced with an increasingly complex stimulant market, in which consumers are confronted with a wide variety of powders and pills. While cocaine, ecstasy and amphetamines continue to be the main players on the stimulant scene, they … Read the full press release →

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 →

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 →