BfArM - Federal Institute for Drugs and Medical Devices

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316 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

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.

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

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

Rubraca® (rucaparib camsylate): Cancer drug review based on preliminary study results Date: 30. September 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: rucaparib camsylate

With the publication of the European Commission Decision on 21 September 2022, the Risk Assessment Procedure under Article 20 of Regulation (EC) No 726/2004 concerning "Rubraca - Rucaparib" was finalised.

Evaluation docx, 25KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

Summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Report template version 4, 2021-06-25

Annex 3.1 complication rates vnd.openxmlformats-officedocument.spreadsheetml.sheet, 43KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

SAE and DD complication rates within clinical investigations or performance studies
Table version 4, 2021-06-25

Notes PDF, 485KB, File does not meet accessibility standards Date: 17. August 2022 Topics: Medical devices Type: Download

Notes on completing the summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Version 4, 2021-06-25