Active substance: obeticholic acid EMA’s human medicines committee (CHMP) has started a review of the medicine Ocaliva (obeticholic acid), used to treat adults with primary biliary cholangitis (PBC).

Active substance: Phenoxymethylpenicillin potassium The company InfectoPharm Arzneimittel und Consilium GmbH informs about a quality defect of the medicinal products InfectoCillin 400 powder for oral solution, 100 ml and InfectoCillin 500 powder for oral solution, 100 ml due to a defect of the cap.

Active substance: naltrexone, bupropion EMA has started a review of Mysimba (naltrexone/bupropion), a medicine for weight management in adults who have obesity or are overweight.

Active substance: fentanyl Marketing authorization holders of fentanyl-containing transdermal patches provide information on the delayed inclusion of an accidental use warning on the outer packaging and, if applicable, the patches sachets.

Active substance: ozanimod Bristol Myers Squibb provides information on the recommendation for dose reduction in mild or moderate chronic hepatic impairment.

Active substance: mitomycine Medac GmbH informs about the lifting of the restrictions on the use of its mitomycin preparations for intravenous administration.

Active substance: Valproat The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating data on the potential risk of neurodevelopmental disorders in children born to men taking valproate-containing medicines.

Active substance: octenidine dihydrochloride Information Letter for healthcare professionals on reducing drug and application risks of Octenident antiseptic.

Active substance: various Information for marketing authorisation holders: Current information on submission for step 2

Active substance: vosoritide BioMarin International Limited in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that from August 2023, Voxzogo co-packs will contain new solvent needles and new administration syringes due to supply chain reasons.

Active substance: levothyroxin sodium Aristo Pharma GmbH informs about a new composition of L-thyroxine Aristo tablets, which will be available from August 2023. A close control is recommended.

Active substance: Dacarbazine Medac Gesellschaft für klinische Spezialpräparate mbH informs about a precautionary recall of the batches G220299AH, D220154AB and D220154AF of the medicinal product Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion.

Active substance: posaconazole Merck Sharp & Dohme B.V. provides information about the new dosage form of Noxafil and the risk of associated medication errors.

Active substance: pralsetinib Roche Pharma AG informs about the occurrence of mostly extrapulmonary tuberculosis in patients treated with Gavreto.

Active substance: ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin The marketing authorisation holders of fluoroquinolone antibiotics in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to remind of the recent study data which suggest that fluoroquinolones continue to be prescribed outside of the recommended uses.