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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

2015.04.10Viread: Possibility of counterfeits of the medicinal product in the legal supply …

The BfArM has received information that counterfeits of the centrally licensed medicinal product Viread 245 mg film-coated tablets are possibly on the market in Germany.

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2015.04.07Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®): …

The BfArM issues information that in Germany up to now overall 9 cases of PML (progressive multifocal leukoencephalopathy) have been reported in connection with the administration of Fumaderm®

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2015.04.07Medicinal products containing kava-kava: Risk of severe hepatic injury, hearing …

Dated 25 February 2015, the Higher Administrative Court of North Rhine-Westphalia has ruled to overturn the BfArM's decision from the end of 2007 to revoke the marketing authorisations of the …

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2015.04.02Quinine for nocturnal leg cramps (Limptar® N): BfArM's notice regarding changes …

The BfArM issues information on a national graduated plan procedure regarding the active substance quinine for the indication nocturnal leg cramps.

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Overview

Risk information on
medical devices

2015.01.29Advices for the application of NaCl basin liners

Advices for the application of NaCl basin liners

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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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Overview

Additional Information

Reporting risks to the BfArM

Advice Procedures