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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.

Direct Healthcare Professional Communication (DHPC) on Gavreto▼ (pralsetinib): Increased risk for tuberculosis and measures to minimize this risk PDF, 389KB, File is accessible Date: 16. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pralsetinib

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

Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolone antibiotics: reminder on restrictions of use PDF, 379KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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 …

Direct Healthcare Professional Communication (DHPC) on Cyclophosphamid beta 500 mg/ml, 1000 mg/2 ml, 2000 mg/4 ml concentrate for solution for injection/infusion (cyclophosphamide): Contraindicated in children and adolescents due to alcohol content PDF, 120KB, File is accessible Date: 01. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Direct Healthcare Professional Communication (DHPC) on recall of the epinephrine auto-injector Emerade® 300/500 microgramm pre-filled pen: Patients should replace product PDF, 1MB, File is accessible Date: 26. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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 …

Direct Healthcare Professional Communication (DHPC) on propofol: risk of sepsis with multiple withdrawals from one container PDF, 172KB, File is accessible Date: 16. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Direct Healthcare Professional Communication (DHPC) on Janus kinase inhibitors: Updated recommendations for risk minimisation Date: 17. March 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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 …