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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 the portfolio of the Federal Ministry of Health. 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 the safety thereof as well as concerning the recording and assessment of risks in connection with medical devices. More

About us

(The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. More

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

Risk information on
medicinal products

2016.01.28Protopic® – Herpes-simplex eye infections

The BfArM points out that herpes simplex infections of the eye have been included as a new adverse reaction in the product information of Protopic®.

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2016.01.14Mycophenolate (e.g. CellCept®): Update on the use of medicinal products …

The BfArM is issuing further information as a follow-up to the reinforced warning of 26 October 2015 regarding the use of mycophenolate (mycophenolate mofetil or mycophenolic acid) during …

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2016.01.14Dear Doctor Letter (Rote-Hand-Brief) on Tarceva® (erlotinib): Restriction of …

The company Roche Pharma AG is circulating a Dear Doctor Letter with information on restrictions regarding the indications of Tarceva®.

2016.01.08Dear Doctor Letter (Rote-Hand-Brief) on Ampicillin+Sulbactam-ratiopharm® 1000/500 mg

The company Ratiopharm GmbH is circulating information that as a precautionary measure it is currently absolutely necessary to use a particle filter when administering the product.

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