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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

2018.08.13Dear Doctor Letter (Rote-Hand-Brief) on hydroxyethyl starch (HES) solutions for …

The marketing authorisation holders inform that hydroxyethyl starch (HES)-containing solutions for infusion have continued to be used in patients with contraindications. Such contraindicated …

2018.08.02Hydroxyethyl-starch containing Medicines: Introduction of new measures to …

In its notice of 31 July2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2018) 4832 …

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2018.07.20Retinoids: Updated measures for pregnancy prevention as well as warnings on …

The Federal Institute for Drugs and Medical Devices (BfArM) is realising the EU Commission's implementing decision. This concludes the European Safety Review on retinoids in accordance with …

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2018.07.17Valsartan: Impurity in the active substance

Update to the review of valsartan-containing medicinal products after an impurity in the active substance has been detected.

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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

Additional Information

Reporting risks to the BfArM