European Medicines Agency

Review to determine whether changes to authorisation are necessary 28-1-2013 — /europawire.eu/ — The European Medicines Agency has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict the use … Read the full press release →

24-1-2013 — /europawire.eu/ — The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100 and 400 mg film-coated tablets. It was … Read the full press release →

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 →