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

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: 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: 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: dolutegravir The European Medicines Agency (EMA) is currently evaluating preliminary results from a study which found 4 cases of birth defects.

Active substances: daclatasvir | dasabuvir | sofosbuvir/ledipasvir | simeprevir | sofosbuvir | ombitasvir/paritaprevir/ritonavir The European Medicines Agency (EMA) confirms its recommendation for hepatitis B screening of all patients before starting treatment with direct-acting antiviral drugs for the treatment of hepatitis C

Active substances: apixaban | dabigatran etexilate | rivaroxaban Following a review of the results of a European study with real-world drug-related data from use, no change in the use criteria of the direct oral anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate), and Xarelto® (rivaroxaban) is required.

Active substance: Ruxolitinib phosphate The company Incyte Biosciences Distribution B.V. informs about possible particles in Opzelura 15 mg/g cream, which may form during production from the active substance.

Active substance: Aztreonam, Avibactam The company Pfizer Europe MA EEIG informs about the risk of broken or cracked glass vials of  Emblaveo 1.5 g/0.5 g  powder for concentrate for solution for infusion.

Active substance: Parathyroid hormone Takeda informs of an expected supply shortage for the medicinal product Natpar 100 micrograms/dose strength due to manufacturing challenges.

Active substance: Quinapril hydrochloride, hydrochlorothiazide Pfizer informs about a precautionary recall of all strengths and package sizes of the medicinal product Accuzide at pharmacy level, as nitrosamine contamination has been detected by investigations.

Active substance: Quinapril hydrochloride Pfizer informs about a precautionary recall of all strengths and pack sizes of the medicinal product Accupro at pharmacy level, as investigations have identified nitrosamine contamination.

Active substance: ingenol mebutate LEO Pharma would like to inform you about the suspension of the marketing authorisation of Picato (ingenol mebutate) as a precautionary measure due to growing concerns on the possible risk of skin malignancy.

Active substance: tofacitinib Pfizer, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), informs that a dose-dependent increased risk of serious venous thromboembolic events has been observed in patients treated with tofacitinib.