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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

2016.11.21Dear Doctor Letter (Rote-Hand-Brief) on oral solutions containing levetiracetam: …

In several cases, oral administration of levetiracetam solutions (100 mg/ml) resulted in accidental (up to 10-fold) overdosage, especially in children aged 11 years and younger.

2016.11.14Marketing authorisations based on studies conducted by the company Alkem …

In a notice dated 13 October 2016, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of a generic marketing authorisation that was based on a …

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2016.11.14Information Letter on Erwinase® 10.000 IU/vial, powder for solution for …

The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that over a period of 4 to 5 weeks there will be temporary shortages as regards new orders of Erwinase®.

2016.11.08Dear Doctor Letter (Rote-Hand-Brief) on Otezla® (apremilast): New important …

The company Celgene GmbH is circulating information regarding occasional cases of suicidal thoughts or behaviour that have been reported from clinical trials and after introduction to the …

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