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

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.

Active substance: azithromycin The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommends changes with regard to the use of the antibiotic azithromycin.

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: Nitrous Oxide, Oxygen The company Linde Sverige AB informs about a quality defect of the medicinal product Livopan when used with a Fir Tree connector for direct connection with O₂/N₂O breathing systems.

Active substance: metamizole With the publication of the European Commission's decision, the risk assessment procedure on the medicinal products containing metamizole has been completed.

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: ribociclib The company Novartis Pharma GmbH informs about a change to storage condtions and shelf life of Kisqali 200 mg film tablets.

Active substance: atomoxetin Update of the Summary of Product Characteristics and Package Leaflet following the European PSUR Single Assessment on atomoxetine.