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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

2015.01.22Medicinal products containing testosterone: Review of possible cardiac risks

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has reviewed the risk of cardiovascular diseases, particularly heart attacks, under treatment with …

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2015.01.16Dear Doctor Letter (Rote-Hand-Brief) on Vibativ® (telavancin): Recommendations …

As a mandatory condition of the marketing authorisation, the company Clinigen is circulating information on the important risks of telavancin (nephrotoxicity, QTc prolongation, reproductive …

2015.01.13Medicinal products containing valproate and related substances: Risk of …

On 19 November 2014, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) decided unanimously based on the recommendations of the European Medicines …

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2015.01.09Medicinal products containing Estradiol for topical administration: Realisation …

In its notice of 9 January 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission …

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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