Navigation and service

focus

  1. About us
  2. Medicinal Products
  3. Federal Opium Agency
  4. Medical Devices
  5. Research
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

2015.08.21Olysio® (simeprevir) in combination with Sovaldi® (sofosbuvir): Risk of severe …

In accordance with the evaluation of cardiac safety of the concomitant administration of Harvoni®, Daklinza® and Sovaldi® with amiodarone, the Pharmacovigilance Risk Assessment Committee (PRAC

more

2015.08.13Dear Doctor Letter (Rote-Hand-Brief) on InductOs 1.5 mg/ml powder, solvent and …

The company Medtronic BioPharma B.V. is circulating information that InductOs is expected to run out of stock as of the end of October 2015.

2015.07.28InductOs (dibotermin alfa): Initiation of a European safety review due to …

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding InductOs (dibotermin alfa), a bone protein that is …

more

2015.07.27Medicinal products containing ibuprofen/dexibuprofen and cardiovascular risk: …

In its notice of 22 July 2015, the BfArM has ruled the realisation of the decision of the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of 20 May 2015 …

more

Overview

Risk information on
medical devices

2015.01.29Advices for the application of NaCl basin liners

Advices for the application of NaCl basin liners

more

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.

more

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

Recall of the intragastric balloon Heliosphere Newtech -Newtech 720.

more

2013.08.27Weld control of the hoist Omnilift G2

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

more

Overview

Additional Information

Reporting risks to the BfArM

Advice Procedures