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.

Active substance: cyclophosphamide betapharm Arzneimittel GmbH informs that cyclophosphamide beta concentrate for solution for injection/infusion is contraindicated for children and adolescents due to the alcohol content.

Active substance: Epinephrine The marketing authorisation holder Pharma Swiss Česká republika s.r.o. and the distributor Dr. Gerhard Mann chem.-pharm. Fabrik GmbH inform in consultation with the local competent authority (Landesamt für Gesundheit und Soziales, Berlin), that all batches of Emerade® pre-filled pens are recalled on patient level.

Active substance: propofol The marketing authorisation holders of propofol-containing medicinal products provide information that propofol-containing medicinal products are only authorised for single use in a single patient.

Active substance: methotrexate The study commissioned by the EMA to review the effectiveness of mandated measures to minimise medication errors in therapy with methotrexate-containing medicinal products has been completed. The study results and possible resulting safety measures will be described and discussed in detail in the next PSUSA procedure for methotrexatehaleradministered by the BfArM.

Active substance: Mitomycin Substipharm informs that the mitomycin-containing medicinal product Mitem® 20 mg - powder for the preparation of a solution for injection or infusion or powder and solvent for the preparation of a solution can be used again for intravenous administration.

Active substance: Janus kinase inhibitors AbbVie, Galapagos, Lilly and Pfizer in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you about the updated recommendations for risk minimisation regarding the Janus kinase inhibitors therapy.

Active substance: Janus kinase inhibitors With the publication of the European Commission's decision on March 10, 2023, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 on Janus kinase inhibitors was completed. The warnings and precautions for using these medicines have been updated.

Active substance: Pholcodine The European Commission made its final legally binding decision on March 06, 2023, resulting in the revocation of national authorizations. This decision, addressed to the EU member states, is valid in all EU member states. This concludes the European risk assessment procedure under Article 107i of Directive 2001/83/EC on medicinal products containing pholcodine.

Active substance: Mercaptamine bitartrate Recordati Rare Diseases informs about a precautionary recall of batch T2208 of the medicinal product Cystagon 150 mg capsules.

Active substances: atovaquone/proguanil hydrochloride | celecoxib | eprosartan | pregabalin | saquinavir No more medicinal products are authorised in Germany that were based on studies conducted by the Semler Research Center (SRC) in India.