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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

2017.03.14Contrast agents containing gadolinium: Deposits in the brain

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to rule suspension of the …

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2017.03.14Medicinal products containing valproate: New review of use during pregnancy and …

The BfArM issues information on the initiation of a safety review by the European Medicines Agency (EMA) to review the use of medicinal products containing valproate in girls and women who are …

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2017.03.06Dear Doctor Letter (Rote-Hand-Brief) on Viridal® 40 µg powder and solvent for …

The company UCB Pharma GmbH is circulating information on a voluntary recall of the medicinal product Viridal® due to defective membranes of the glass cartridges.

2017.02.10Fluorquinolones and quinolones for systemic use or inhalation: European safety …

The BfArM has initiated a European safety review on fluorquinolones and quinolones. These antibiotics are to be scientifically reviewed with regard to potential, long-lasting and possibly …

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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