Active substance: domperidone In its notice of 8 September 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)5113. The European safety review according to Article 31 of Directive 2001/83/EC regarding medicinal products containing domperidone is thus now concluded.

Active substance: dronedarone The European Medicines Agency is currently reviewing the benefit-risk balance of the antiarrhythmic agent dronedarone (Multaq^®). New study data (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients with permanent atrial fibrillation due to treatment with dronedarone. In January 2011 the CHMP already initiated a procedure to review the benefit-risk balance following reports of severe liver injury including hepatic failure due to dronedarone.

Active substance: The analytical results of a retrospective series of case-control studies yielding information on several types of birth defects in newborn babies in connection with the use of Duogynon during early pregnancy are now available to the BfArM.

Active substance: different Parallel importers are requested to comment in a hearing pursuant to the graduated plan.

Active substance: The BfArM calls attention to the public announcement made by the European Medicines Agency (EMA) in co-ordination with the European licensing authorities following the radiation leak from the Fukushima Daiichi nuclear power plant in Japan.

Active substance: Idelalisib EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia.

Active substance: buflomedil The Committee for Medicinal Products on Human Use (CHMP) of the European Medicines Agency (EMA) has completed its review of the benefit/risk balance of buflomedil and has come to a negative conclusion. The EMA recommends that all marketing authorisations for medicines containing buflomedil should be suspended throughout the Member States of the EU.

Active substance: sofosbuvir, velpatasvir The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the company Gilead's medicinal product Epclusa® 400 mg/100 mg film-coated tablets was offered to a wholesaler in Germany.

Active substance: ulipristal acetate The European risk assessment procedure for Esmya® has been completed following the EU Commission's decision.

Active substance: metformin EU regulators request nitrosamine testing of metformin medicines

Active substance: FMT The American Food and Drug Administration (FDA) warns of the risk of serious bacterial infections caused by the transmission of multi-resistant bacteria during faecal microbiota transplants (FMT).

Active substance: fenspirid The PRAC recommendation was adopted by the CMDh by consensus and will be implemented directly at national level.

Active substance: insulin aspart The colour of cartridges of the pre-filled pens and vials of the rapid-acting insulin Fiasp® is changing from yellow to red and yellow, as there have been reports of cases where patients mistakenly injected Fiasp® instead of the long-acting insulin Tresiba® (available in the EU as light green cartridges and pens) or the other way around.

Active substance: finasteride, Dutasteride CMDh recommends measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines.

Active substances: fluoroquinolones | quinolones In response to enquiries, the BfArM refers at this point to Annex II of the Commission Decision, which describes areas of application in Category 1.