BfArM - Federal Institute for Drugs and Medical Devices

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Amfepramone-containing medicines are no longer available on the EU market, as marketing authorisations have been revoked respectively withdrawn.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