Navigation and service

focus

  1. About us
  2. Medicinal Products
  3. Federal Opium Agency
  4. Medical Devices
  5. Research
Federal Institute for Drugs and Medical Devices

About us

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within th … More

Medical Products

Medicinal Products

Medicinal products are substances that are used to treat diseases, to relieve complaints, or to prevent such diseases or complaints in the first place. More

Federal Opium Agency

Federal Opium Agency

The Bundesopiumstelle (Federal Opium Agency) is one of 13 departments at the Federal Institute for Drugs and Medical Devices. More

Medical Devices

Medical Devices

Medical devices are products that have a medical purpose and are intended by the manufacturer for use in humans. More

Research

Research

Research at the BfArM concentrates on important and contemporary research focal points with regard to the marketing authorisation of medicinal products and improving … More

About us

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within th … More

  1. Risk information on
    medicinal products
  2. Risk information on
    medical devices

Risk information on
medicinal products

2014.10.28Dear Doctor Letter (Rote-Hand-Brief) on Beofenac® (aceclofenac): New …

The company Almirall Hermal GmbH is circulating information that treatment with aceclofenac - similar to that with diclofenac and selective COX-2 inhibitors - is associated with an increased …

2014.10.24Medicinal products containing ponatinib (Iclusig): Confirmation of the …

The BfArM issues information on the fact that the PRAC's recommendation has been confirmed by the European Committee for Medicinal Products (CHMP) within a European safety review in accordance …

more

2014.10.10Use of valproate (and related substances) during pregnancy: Recommendation of …

The BfArM issues information on the PRAC's recommendation within a European safety review according to Article 31 of Directive 2001/83/EC.

more

2014.10.10Medicinal products containing ponatinib (Iclusig): Recommendation of the …

The BfArM issues information on the PRAC's recommendation within a European safety review in accordance with Article 20 of Regulation (EC) No. 726/2004.

more

Overview

Risk information on
medical devices

2014.03.20Recommendation in relation to the recall of the intragastric balloon Heliosphere …

Recall of the intragastric balloon Heliosphere Newtech -Newtech 720.

more

2013.08.27Weld control of the hoist Omnilift G2

Weld control of the hoist Omnilift G2 of the former manufacturer Weiner Innovative Medizintechnik

more

2013.03.12IV extension sets with multiple ports and vented caps

BfArM informs about the potential risk of air embolism when using IV extension sets with multiple ports and vented caps

more

2012.09.28FlowMedical PTA-CATH 5,0 x 100 Angioplasty Catheter of the manufacturer itm …

The recommendation that the Angioplasty Catheter FlowMedical PTA-CATH 5,0 x 100 of the manufacturer itm FlowMedical GmbH should not be used anymore is cancelled by BfArM

more

Overview

Additional Information

Reporting risks to the BfArM

Advice Procedures