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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

2018.12.11Dear Doctor Letter for contraceptives containing dienogest and ethinylestradiol: …

The company Jenapharm GmbH & Co. KG provides information on the risk of venous thromboembolism (VTE) in women using contraceptives containing dienogest and ethinylestradiol compared to …

2018.12.06Information Letter on Palexia® 20 mg/ml oral solution (tapentadol): …

The company Grünenthal is circulating information on a new dosing pipette for weight-based dosing in children with a body weight of more than 16 kg.

2018.11.20Risk information for Colchicum-Dispert® and Colchysat®Bürger by the company Bürger

Based on reports of overdosage leading to death, the dosing recommendations and warnings have been updated.

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2018.11.15Suicidal tendencies possibly linked to depression associated with use of …

As a result of a signal procedure on the risk of suicidal tendencies in connection with the use of hormonal contraceptives, a new warning is to be included in the Summary of Product …

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Overview

Risk information on
medical devices

2018.12.14Increased occurrence of corneal haze after implantation of the Raindrop Near …

According to new clinical study results, the Raindrop implant (Brand name: Raindrop Near Vision Inlay; manufacturer: ReVision Optics) may lead to an increased occurrence of corneal haze.
The

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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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Overview

Additional Information

Reporting risks to the BfArM