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  2. Medicinal Products
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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

2014.07.16Information Letter on Velcade 3.5 MG (PZN 00822831) – Further information …

As a follow-up to the already published precautionary recall of a batch of Velcade®, the pharmaceutical manufacturer has compiled further information.

2014.07.14Oral bromocriptine-containing medicines indicated for prevention or suppression …

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC.

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2014.07.14Medicinal products containing methadone with povidone (polyvinylpyrrolidone) as …

The BfArM issues information on the PRAC recommendation within a European safety review according to Article 107i of Directive 2001/83/EC.

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2014.06.27Dantrolene sodium (DANTROLEN i.v.®): Use of filter needles to draw up …

The company Norgine GmbH is circulating information that some vials of dantrolene sodium for intravenous use after reconstitution may contain visible particles of the active substance.

Overview

Risk information on
medical devices

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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2013.03.12IV extension sets with multiple ports and vented caps

BfArM informs about the potential risk of air embolism when using IV extension sets with multiple ports and vented caps

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2012.09.28FlowMedical PTA-CATH 5,0 x 100 Angioplasty Catheter of the manufacturer itm …

The recommendation that the Angioplasty Catheter FlowMedical PTA-CATH 5,0 x 100 of the manufacturer itm FlowMedical GmbH should not be used anymore is cancelled by BfArM

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Overview

Additional Information

Reporting risks to the BfArM

Advice Procedures