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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

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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2016.12.21Information Letter on Kyprolis® 30 mg vial (carfilzomib): Recall due to possible …

The company Amgen is circulating information on a voluntary recall of the medicinal product Kyprolis® 30 mg vial.

2016.12.20Recall of the medicinal product Tranexamsäure Carino 100 mg/ml, 5 ml ampoules, …

The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to the recall of batch 013024 of the medicinal product Tranexamsäure Carino 100 mg/ml by the company Carinopharm GmbH.

2016.12.13Information letter on Ammonaps® (sodium phenylbutyrate) tablets and granules: …

In view of failings found in the manufacturing site of Ammonaps® (sodium phenylbutyrate) the company Swedish Orphan Biovitrum International AB (Sobi) is circulating information on temporary …

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

Advice Procedures