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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 …

Direct Healthcare Professional Communication (DHPC) on Cystagon 150 mg of the company Recordati Rare Diseases: Recall of batch T2208 PDF, 347KB, File is accessible Date: 27. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Mercaptamine bitartrate

Recordati Rare Diseases informs about a precautionary recall of batch T2208 of the medicinal product Cystagon 150 mg capsules.

Information Letter on Separation of the combined indications for methotrexate medac 25 mg/ml solution for injection (in vials) PDF, 132KB, File is accessible Date: 15. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Methotrexate

The product Methotrexat medac 25 mg/ml solution for injection (in vials) with the marketing authorisation number 80379.00.00 is only available for oncological indications.

Direct Healthcare Professional Communication (DHPC) on amfepramone-containing medicines: Withdrawal and revocation of approvals PDF, 479KB, File is accessible Date: 06. February 2023 Type: Direct Healthcare Professional Communication

Active substance: amfepramone

Amfepramone-containing medicines are no longer available on the EU market, as marketing authorisations have been revoked respectively withdrawn.

Direct Healthcare Professional Communication (DHPC) on Caprelsa® (vandetanib): Restriction of indication PDF, 284KB, File is accessible Date: 02. January 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vandetanib

Sanofi informs that data from a randomized trial and an observational study show insufficient efficacy of vandetanib in patients without identified RET mutations.

Direct Healthcare Professional Communication (DHPC) on terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS) PDF, 448KB, File is accessible Date: 01. December 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: terlipressin

Terlipressin may cause severe or lethal respiratory failure in patients with hepatorenal syndrome type 1 (HRS-1) with a higher frequency than previously known, as well as increase the risk of sepsis or septic shock.

Direct Healthcare Professional Communication (DHPC) on Xalkori® (Crizotinib): Visual disturbances, including risk of vision loss, need for monitoring in pediatric patients PDF, 212KB, File does not meet accessibility standards Date: 11. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Crizotinib

Pfizer informs that pediatric patients should be screened for visual impairment.

Direct Healthcare Professional Communication (DHPC) on chlormadinone acetate and nomegestrol acetate: Measures to minimise the risk of meningioma PDF, 412KB, File is accessible Date: 09. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: chlormadinone, nomegestrol

The marketing authorisation holders of chlormadinone- and nomegestrol- containing medicines would like to inform you that medicinal products containing chlormadinone acetate or nomegestrol acetate are only indicated when other interventions are …

Direct Healthcare Professional Communication (DHPC) on Imbruvica® (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events PDF, 167KB, File does not meet accessibility standards Date: 03. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibrutinib

Janssen-Cilag International NV in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Ibrutinib increases the risk of fatal and serious cardiac arrhythmias …

Direct Healthcare Professional Communication (DHPC) on Custodiol® cardioplegic solution/ organ preservation solution, 500 ml and 1000 ml bottles: risk of visible particles in the solution, use of a filter PDF, 307KB, File does not meet accessibility standards Date: 07. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Direct Healthcare Professional Communication (DHPC) on Custodiol® cardioplegic solution/ organ preservation solution, 500 ml and 1000 ml bottles: risk of visible particles in the solution, use of a filter

Direct Healthcare Professional Communication (DHPC) on Natpar 100 microgram/dose powder and solvent for solution for injection of the company Takeda: Discontinuation of manufacturing at the end of 2024 and update on shortage of 100 microgram/dose PDF, 302KB, File is accessible Date: 07. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Parathyroid hormone

Takeda informs of an expected supply shortage for the medicinal product Natpar 100 micrograms/dose strength due to manufacturing challenges.