Navigation and service

focus

  1. Medicinal Products
  2. Federal Opium Agency
  3. Medical Devices
  4. Research
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

2017.10.27Flupirtine: New European review procedure started

The European Medicines Agency (EMA) has again initiated a review procedure regarding medicinal products containing flupirtine for pain relief. The medicinal products are still being …

more

2017.10.27The European Medicines Agency (EMA) is starting a new review of medicinal …

The BfArM issues information on the initiation of a European safety review according to Article 107i of Directive 2001/83/EC regarding medicinal products containing HES. Studies show low …

more

2017.08.14Information letter on ERWINASE ® 10,000 IU/vial powder for solution for …

Due to shortage, ERWINASE® 10,000 IU/vial powder for solution for injection is currently only available under consideration of the provisions of Section 73 (3) AMG.

more

2017.08.14Counterfeits of the medicinal product VELCADE® 3.5 mg powder for solution for …

The Federal Institute for Drugs and Medical Devices (BfArM) is issuing information on counterfeits of the medicinal product VELCADE 3.5 mg powder for solution for injection by Janssen-Cilag …

more

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

more

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.

more

2015.01.29Advices for the application of NaCl basin liners

Advices for the application of NaCl basin liners

more

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.

more

Overview