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Federal Institute for Drugs and Medical Devices

About us

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within th … More

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 … More

About us

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within th … More

  1. Risk information on
    medicinal products
  2. Risk information on
    medical devices

Risk information on
medicinal products

2015.06.16SGLT2 inhibitors: Initiation of a European safety review to evaluate the risk of …

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.

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2015.06.16Information letter on Kineret® (anakinra) 100 mg and 100 mg/0.67 ml solution for …

The Swedish company Orphan Biovitrum AB (Sobi) issues information on deposits of the active substance on the surface of the needle.

2015.05.26Medicinal products containing ibuprofen and cardiovascular risk: Confirmation of …

The BfArM issues information that the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDH) has confirmed the PRAC's recommendation within the European safety …

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2015.05.20Medicinal products containing hydroxyzine: cardiac (arrhythmogenic) risks …

The Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously decided further measures to minimise the risk of arrhythmias.

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Overview

Risk information on
medical devices

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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2014.03.20Recommendation in relation to the recall of the intragastric balloon Heliosphere …

Recall of the intragastric balloon Heliosphere Newtech -Newtech 720.

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2013.08.27Weld control of the hoist Omnilift G2

Weld control of the hoist Omnilift G2 of the former manufacturer Weiner Innovative Medizintechnik

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Overview

Additional Information

Reporting risks to the BfArM

Advice Procedures