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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

2017.04.18Dienogest 2 mg and ethinylestradiol 0.03 mg for treatment of acne: use for …

In its notice of 5 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2017) …

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2017.04.18Medicinal products containing valproate: Risks of use during pregnancy

In view of renewed discussions and assessments on a European level as well as current findings and discussions with scientific societies, the BfArM also considers it necessary to introduce a …

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2017.04.12Renewed information on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and …

The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that, due to a temporary shortage, Erwinase® 10.000 I.U./vial powder for solution for injection is …

2017.04.10Contrast agents containing gadolinium: Deposits in the brain

Some of the marketing authorisation holders affected by the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of March 2017, have requested a renewed assessment of the …

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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