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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

2014.12.12Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing valproate …

Important new information and increased safety warnings with regard to medicinal products containing valproate and related substances (sodium valproate, valproic acid, valproate semisodium and …

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2014.12.11Dear Doctor Letter (Rote-Hand-Brief) on Procoralan® (ivabradine): New …

The company Servier Deutschland GmbH is circulating information that concomitant use of ivabradine with verapamil or diltiazem is now contraindicated.

2014.12.09Marketing authorisations based on studies conducted by GVK Biosciences in India: …

In a notice dated 8 December 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the suspension of several marketing authorisations that were based on a clinical trial …

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2014.12.04Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): …

The company Biogen Idec GmbH is circulating information on a fatal case of progressive multifocal leukoencephalopathy (PML) in a patient with a severe and long-term lymphopenia treated with …

Overview

Risk information on
medical devices

2014.11.18Recommendations on the approach to patients with Riata and Riata ST leads (St.

The German Cardiac Society (DGK) has published recommendations regarding patients with silicone insulated defibrillation leads Riata and Riata ST of St. Jude Medical.

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

Recall of the intragastric balloon Heliosphere Newtech -Newtech 720.

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2013.08.27Weld control of the hoist Omnilift G2

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

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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

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Overview

Additional Information

Reporting risks to the BfArM

Advice Procedures