BfArM - Federal Institute for Drugs and Medical Devices

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107 results

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Contrast agents containing gadolinium: deposits in the brain and other tissues Date: 16. February 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gadolinium

For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.

Valproate: risk of congenital malformations and developmental problems associated with use during pregnancy Date: 12. January 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

Educational material on medicinal products containing valproate

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 | HES

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

Ocaliva: review started Date: 13. October 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: obeticholic acid

EMA’s human medicines committee (CHMP) has started a review of the medicine Ocaliva (obeticholic acid), used to treat adults with primary biliary cholangitis (PBC).

Information for marketing authorisation holders: current information on submission for step 2 Date: 04. August 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

Information for marketing authorisation holders: Current information on submission for step 2

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.

Terlipressin-containing medicinal products: safety review Date: 30. December 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: terlipressin

The BfArM has implemented the decision of the CMDh dated 10 November 2022 regarding terlipressin-containing drugs at national level by official notice, dated 19 December 2022.