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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 the portfolio of the Federal Ministry of Health. 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 the safety thereof as well as concerning the recording and assessment of risks in connection with medical devices. More

About us

(The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. More

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

Risk information on
medicinal products

2016.08.23Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (Idelalisib): Updated …

The company Gilead Sciences GmbH is circulating information on the updated indication of idelalisib as first-line treatment of patients with chronic lymphocytic leukaemia (CLL) and on risk …

2016.08.09Marketing authorisations based on studies performed at the Semler Research …

In a notice dated 8 August 2016, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled a provisional suspension of the marketing authorisations of several generic medicinal …

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2016.07.20Viread 245 mg and Truvada 200 mg: Counterfeit medicinal products discovered

The Federal Institute for Drugs and Medical Devices (BfArM) warns that counterfeits of the medicinal products Viread 245 mg film-coated tablets and Trudava 200 mg film-coated tablets have been …

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2016.07.19Arcoxia® (etoricoxib): Altered dosage recommendations for patients with …

The company MSD is circulating information on altered dosage recommendations for the medicinal product Arcoxia®.

Overview

Risk information on
medical devices

2016.05.19Cleaning and disinfection of heater-cooler-units (HCUs): possible influence on …

Cleaning and Disinfection of heater-cooler-units (HCUs): possible influence on oxygenator integrity

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2016.05.13Urogynecological use of surgical meshes

The BfArM would like to draw attention to the recent SCENIHR publication regarding the use of surgical meshes in urogynecological surgery.

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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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Overview

Additional Information

Reporting risks to the BfArM

Advice Procedures