BfArM - Federal Institute for Drugs and Medical Devices

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13 results

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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.

Topiramate-containing medicinal products: Risks associated with the use of topiramate during pregnancy and in women of childbearing age. Date: 01. December 2023 Type: Risk information

Active substance: topiramate

In a decision dated 22 November 2023, the Federal Institute for Drugs and Medical Devices (BfArM) implements the unanimous decision of the Coordination Group for Mutual Recognition Procedures and Decentralized Procedures - Human (CMDh) of 11 October …

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.

Valproate: Evaluation of data on paternal exposure by the PRAC Date: 16. August 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating data on the potential risk of neurodevelopmental disorders in children born to men taking valproate-containing medicines.

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.

Methotrexate-containing medicinal products: Improving risk awareness by changing risk-minimising measures - results of a study commissioned by the EMA Date: 30. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: methotrexate

The study commissioned by the EMA to review the effectiveness of mandated measures to minimise medication errors in therapy with methotrexate-containing medicinal products has been completed. The study results and possible resulting safety measures …

Information Letter on Mitem 20 mg of the company Substipharm: Withdrawal of the restriction for intravenous administration PDF, 86KB, File does not meet accessibility standards Date: 22. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: mitomycin

Substipharm informs that the mitomycin-containing medicinal product Mitem® 20 mg - powder for the preparation of a solution for injection or infusion or powder and solvent for the preparation of a solution can be used again for intravenous …

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 …

Pholcodine: Risk of anaphylactic reactions Date: 14. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: pholcodine

The European Commission made its final legally binding decision on March 06, 2023, resulting in the revocation of national authorizations. This decision, addressed to the EU member states, is valid in all EU member states. This concludes the European …