BfArM - Federal Institute for Drugs and Medical Devices

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Iris Meetings – Save the Dates Date: 14. December 2023 Topics: Kodiersysteme Type: News

The dates and information for the next Iris meetings are available.

Hydroxyethyl-starch containing Medicines: Introduction of new measures to protect patients Date: 24. November 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyethyl starch

The Federal Institute for Drugs and Medical Devices (BfArM) publishes updated information on marketability.

Iris version 6 is available for testing with ICD-11 Date: 31. October 2023 Topics: Kodiersysteme Type: News

The first test version of Iris version 6 for ICD-11 mortality coding has been released. You will find version 6.0.17 and the Iris Manual under “Downloads” on our website.

Update of decision tables available Date: 25. April 2023 Topics: Kodiersysteme Type: News

We published updates of the decision tables (specV2021SR40Muse). The new tables are available in the Iris download area.

Janus kinase inhibitors: Treatment of inflammatory disorders Date: 14. March 2023 Type: Risk Assessment Procedures

Active substance: Janus kinase inhibitors

With the publication of the European Commission's decision on March 10, 2023, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 on Janus kinase inhibitors was completed. The warnings and precautions for using …

Marketing authorisations based on studies performed at the Semler Research Center (SRC) Private Ltd. company in India: suspension of marketing authorisations Date: 15. February 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: atovaquone, proguanil hydrochloride, celecoxib, eprosartan, pregabalin, saquinavir

No more medicinal products are authorised in Germany that were based on studies conducted by the Semler Research Center (SRC) in India.

Amfepramone: Safety review Date: 08. February 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: amfepramone

Following the recommendation of the Coordination Group on Mutual Recognition Procedures and Decentralised Procedures - Human (CMDh) on the revocation of marketing authorisations and prior to the final decision of the European Commission, all …

Sartans: Contamination of active ingredients Date: 03. January 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valsartan | candesartan | irbesartan | losartan | olmesartan

The Federal Institute for Drugs and Medical Devices (BfArM) has withdrawn the suspension of some of axcount's marketing authorizations by decision dated December 22, 2022.