BfArM - Federal Institute for Drugs and Medical Devices

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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.

Which powers of attorney should be included with the application? Date: 22. November 2022 Topics: Medical devices Type: FAQ

In the case of an application for authorisation of a clinical investigation under the MDR or a performance study under the IVDR, a power of attorney for the legal representative of the sponsor in the Union (cf. Article 62 (2) and (4) (c) MDR or …

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.

Direct Healthcare Professional Communication (DHPC) on Nulojix® (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg PDF, 217KB, File does not meet accessibility standards Date: 04. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: belatacept

Bristol Myers Squibb in agreement with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that With the implementation of a new manufacturing process, the maintenance dose for …

Which SAE and DD reporting obligations apply from the date of application of the MDR in Germany? Date: 17. August 2022 Topics: Medical devices Type: FAQ

Information on SAE and DD reporting requirements can be found in the Applications and Reports section.

Is there a transition period for applications for authorisation of a clinical investigation of medical devices? Date: 17. August 2022 Topics: Medical devices Type: FAQ

In Germany, the legislation provides for a cut-off date for the transition to the new legislation for clinical investigations of medical devices. This means that all applications must be submitted and processed according to the legislation valid …