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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

2018.01.17Information Letter on noradrenaline

The company Aguettant issues information on the marketing of a solution for infusion containing noradrenaline in two new ready-for-use strengths.

2018.01.15Information letter on Haldol® (tablets, oral drops, solution, solution for …

Due to questions regarding the recently circulated Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing haloperidol, the company Janssen-Cilag GmbH (Haldol®-Janssen) would …

2018.01.12PRAC recommends suspension of marketing authorisations for medicinal products …

In the course of the European safety review according to Article 107i of Directive 2001/83 initiated in October of 2017, the Pharmacovigilance Risk Assessment Committee (PRAC) has recommended …

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2018.01.10Dear Doctor Letter (Rote-Hand-Brief) on contrast media containing gadolinium: …

The marketing authorisation holders concerned are circulating information on indications confirmed by the European Medicines Agency (EMA) regarding low levels of gadolinium deposition in the …

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