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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

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

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

Risk information on
medicinal products

2017.07.04Symbioflor 2: Recommendations of the Committee for Medicinal Products for Human …

In its review of Symbioflor 2, the European Medicines Agency EMA has concluded that the medicinal product can continue to be used for treatment of irritable bowel syndrome in adults. However, …

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2017.05.18Epclusa® 400 mg/100 mg film-coated tablets (batch 15SFPD119): Counterfeit in …

The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the company Gilead's medicinal product Epclusa® 400 mg/100 mg film-coated tablets was offered to a …

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2017.05.12Marketing authorisations based on studies conducted by the company Micro …

In a notice dated 12 May 2017, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of various generic marketing authorisations that were based on …

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2017.05.08Direct-acting antivirals used for treating hepatitis C: Possible hepatitis B …

The BfArM issues information on the initiation of a European safety review regarding direct-acting antiviral medicinal products for treatment of chronic hepatitis C (HCV), an infectious …

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Overview

Risk information on
medical devices

2016.12.22Cleaning 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