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818 results

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Mysimba: potential long-term cardiovascular risk Date: 15. September 2023 Topics: Pharmakovigilanz Type: Risk information

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.

Direct Healthcare Professional Communication (DHPC) on fentanyl-containing transdermal patches: late inclusion of a warning on accidental use PDF, 426KB, File is accessible Date: 01. September 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Information Letter on Zeposia (Ozanimod): Modified dosing recommendation for mild or moderate chronic hepatic impairment (Child-Pugh class A or B) PDF, 134KB, File is accessible Date: 18. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ozanimod

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

The restrictions on the use of mitomycin preparations from Medac GmbH for intravenous administration are lifted PDF, 484KB, File does not meet accessibility standards Date: 17. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mitomycine

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

Valproate: Evaluation of data on paternal exposure by the PRAC Date: 16. August 2023 Topics: Pharmakovigilanz Type: Risk information

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.

Information for marketing authorisation holders: current information on submission for step 2 Date: 04. August 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

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

Direct Healthcare Professional Communication (DHPC) on Voxzogo® (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL PDF, 243KB, File is accessible Date: 01. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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 …

Direct Healthcare Professional Communication (DHPC) on L-Thyroxin Aristo (levothyroxine sodium): Tablets in new composition - information and close monitoring of patients during the switch PDF, 850KB, File does not meet accessibility standards Date: 17. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Direct Healthcare Professional Communication (DHPC) on Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion of the company Medac: Recall of three batches PDF, 232KB, File does not meet accessibility standards Date: 14. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Direct Healthcare Professional Communication (DHPC) on Noxafil (posaconazole): new dosage form – risk of medication error PDF, 434KB, File does not meet accessibility standards Date: 07. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: posaconazole

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