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.