May 17, 2013
- Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Products (ANSM) unexpectedly announced today the decision to suspend the marketing authorisations of these medicines in France.
- The European Medicines Agency supports International Clinical Trials Day, which is taking place on Monday 20 May 2013.
- The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for ProZinc (insulin human) from Boehringer Ingelheim Vetmedica GmbH, for the treatment of diabetes mellitus in cats to achieve reduction of hyperglycaemia and improvement of associated clinical signs.
- The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the marketing authorisation for Aftovaxpur DOE for use in response to outbreaks of foot-and-mouth disease (FMD).
- The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in the veins and arteries).
- The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics outweigh the risks in a specific patient group, provided that several measures are taken to minimise the risk of thromboembolism, including new contraindications and warnings.
May 16, 2013
- The European Medicines Agency will be closed from 6.30pm on Friday 17 May until 7.30am on Tuesday 21 May 2013.
- The European Medicines Agency supports World Hypertension Day, which is taking place on Friday 17 May 2013.
May 8, 2013
- The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction.
- The European Medicines Agency (EMA) has revised its overarching guideline on similar biological medicines and published a draft for public consultation.