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: 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: 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: fezolinetant The marketing authorisation holder of Veoza (fezolinetant) would like to inform about the risk of drug-induced liver injury.

Active substance: voxelotor The European Commission has decided to suspend the marketing authorization for the medicinal product Oxbryta (voxelotor) for sickle cell disease. This is a precautionary measure during the review of new data.

Active substance: metamizole The marketing authorisation holders of metamizole-containing medicinal products provide information on the early symptoms of agranulocytosis.

Active substance: Hydroxycobalamin The company SERB SA informs about a potential microbial contamination and a possible resulting risk of infection.

Active substance: Budesonide and Formoterole The company Sandoz GmbH informs about a possible failure of dose delivery in several batches of Airbufo Forspiro.

Active substance: 5-Fluorouracil The marketing authorisation holders of 5-fluorouracil containing medicines would like to inform that in patients with moderate or severe renal impairment, blood uracil levels used for dihydropyrimidine dehydrogenase (DPD) phenotyping should be interpreted with caution as there is an increased risk of misdiagnosis of DPD deficiency, which may lead to underdosing of 5-fluorouracil and thus reduced treatment efficacy.

Active substance: medroxyprogesterone acetate The marketing authorisation holder of medroxyprogesterone acetate-containing medicines would like to inform you about the increased risk of developing meningioma with high doses of medroxyprogesterone acetate.

Active substance: voxelotor Pfizer Europe would like to inform you that the marketing authorisation for Oxbryta is suspended in the European Union as a precautionary measure while the review of the benefits and risks is ongoing.

Active substance: finasteride, Dutasteride EMA starts safety review of medicines containing finasteride and dutasteride