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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

2017.02.10Fluorquinolones 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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2017.02.09Medicinal products containing colchicine (Colchysat Bürger®) and reports of …

The BfArM issues information on the initiation of a graduated plan procedure concerning the medicinal product Colchysat Bürger®.

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2017.01.31Information Letter on Erwinase® 10.000 IU/vial, powder for solution for …

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 …

2016.12.28Norditropin® SimpleXx® 15 mg/1,5 ml (Badge DC80754): Counterfeit in the illegal …

The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the medicinal product Norditropin® SimpleXx® 15 mg/1,5 ml solution for injection by the company Novo …

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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