Active substance: finasteride, dutasteride The Federal Institute for Drugs and Medical Devices (BfArM) implements the final decision of the EU Commission nationally.

Active substance: finasteride, dutasteride The marketing authorisation holders of finasteride- and dutasteride-containing medicinal products provide information on suicidal thoughts as an adverse drug reaction of orally administered finasteride-containing products.

Active substance: azithromycin The European Commission's final decision on the risk assessment procedure for azithromycin has been published.

Active substance: isoniazid Esteve Pharmaceuticals GmbH has issued a warning about visible particles in batch 286490A of the medicinal product Isozid 0.5 N powder for solution for infusion after reconstitution.

Active substance: clozapine The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.

Active substance: levamisole The European Medicines Agency (EMA) is initiating a safety review of medicines containing levamisole for the treatment of parasitic worm infections.

Active substance: soya bean oil, refined, medium-chain triglycerides, omega-3-acid triglycerides Braun Melsungen AG informs about agglomerates consisting of droplet-like structures that have been detected in individual batches of the medicinal product.

Active substance: betaine SERB Pharmaceuticals has reported that three batches were packaged for the German market with a faulty PZN number in the NTIN-DE and in the 2D barcode.

Active substance: Risdiplam The marketing authorization holder Roche Registration GmbH informs about the omission of a mandatory labelling statement on the bottle labels, product carton, summary of product characteristics and Instruction for
Constitution.

Active substance: thalidomide, lenalidomide, pomalidomide The Federal Institute for Drugs and Medical Devices (BfArM) once again draws attention to the applicable safety regulations and the requirements for the proper prescription of thalidomide, lenalidomide and pomalidomide.

Active substance: various Information for marketing authorisation holders: Current information on submission for step 3

Active substance: misoprostol Reminder of the authorisation-compliant application.

Active substance: odium oxybate The European Medicines Agency (EMA) is starting to review medicines containing sodium oxybate.

Active substance: naltrexone, bupropion EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation).

Active substance: Ipidacrin The European Medicines Agency (EMA) is starting to review medicines containing ipidacrine.