BfArM - Federal Institute for Drugs and Medical Devices

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571 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.

Current information from the BfArM on the restricted availability of paracetamol- and ibuprofen-containing fever-containing juices for children Date: 22. December 2022 Type: Article

On 30th November 2022, the Advisory Council for Delivery and Supply Shortages according to section 52b subsection 3b of the Medicinal Products Act (AMG) held a meeting to discuss further measures to mitigate the shortages of paediatric medicines …

CHMP Meeting Highlights December 2022 Date: 22. December 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights December 2022

ATC-Classification Date: 20. December 2022 Topics: Kodiersysteme Type: Article

BfArM publishes the annually updated official version of the German Anatomical Therapeutic Chemical (ATC)-Classification with defined daily doses (DDD) since January 1st, 2004.

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.

Folinic acid Date: 13. December 2022 Type: Article

In spring 2022, the BfArM was informed of the limited availability of calcium folinate-containing medicinal products in parenteral administration via the supply shortage online portal.

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.

Application for a decision on the authorisation requirement of a clinical trial of a medical device or a performance study of an in vitro diagnostic medical device Date: 22. November 2022 Topics: Medical devices Type: Article

If the regulatory classification of a planned clinical investigation or performance study cannot be clarified, the parties involved in the conduct, authorisation or monitoring of the clinical investigation / performance study may submit an …

Antibiotic resistance: Slowing down its development, saving lives Date: 17. November 2022 Type: Article

In its battle against various types of antimicrobial resistance, the BfArM focuses especially on the necessity of state-of-the-art information for experts.