BfArM - Federal Institute for Drugs and Medical Devices

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789 results

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Terlipressin-containing medicinal products: Safety review Date: 30. December 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: terlipressin

The BfArM has implemented the decision of the CMDh dated 10 November 2022 regarding terlipressin-containing drugs at national level by official notice, dated 19 December 2022.

Studies at Synchron Research Services, India: review with regard to the conduct of studies Date: 19. December 2022 Type: Risk Assessment Procedures

Active substance: various

The Federal Institute for Drugs and Medical Devices (BfArM) implements the EU Commission's implementing decision of 28.11.2022 nationally by notice of 13 December 2022.

ORPHANET - 25 Years and Counting PDF, 6MB, File does not meet accessibility standards Date: 13. December 2022 Topics: Kodiersysteme Type: Download

ORPHANET - 25 Years and Counting

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.

Medicines containing nomegestrol or chlormadinone: Risk of meningioma Date: 24. November 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: nomegestrol, chlormadinone

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission C(2022) 7954 (final) of 28.10.2022 with a notice in the national graduated plan procedure, dated 22 November 2022.

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 …

Agenda Iris User Group Meeting 2022 PDF, 140KB, File is accessible Date: 08. November 2022 Topics: Kodiersysteme Type: Download

Agenda Iris User Group Meeting 2022

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 …

Presentation Iris-11 Webinar - September 2023 zip, 5MB, File does not meet accessibility standards Date: 11. October 2022 Topics: Kodiersysteme Type: Download

Presentation Iris-11 Webinar - September 2023