BfArM - Federal Institute for Drugs and Medical Devices

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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 …

Direct Healthcare Professional Communication (DHPC) on Cystagon 150 mg of the company Recordati Rare Diseases: Recall of batch T2208 PDF, 347KB, File is accessible Date: 27. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Mercaptamine bitartrate

Recordati Rare Diseases informs about a precautionary recall of batch T2208 of the medicinal product Cystagon 150 mg capsules.

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.

Information Letter on Separation of the combined indications for methotrexate medac 25 mg/ml solution for injection (in vials) PDF, 132KB, File is accessible Date: 15. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Methotrexate

The product Methotrexat medac 25 mg/ml solution for injection (in vials) with the marketing authorisation number 80379.00.00 is only available for oncological indications.

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.

Direct Healthcare Professional Communication (DHPC) on Caprelsa® (vandetanib): Restriction of indication PDF, 284KB, File is accessible Date: 02. January 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vandetanib

Sanofi informs that data from a randomized trial and an observational study show insufficient efficacy of vandetanib in patients without identified RET mutations.

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.

Direct Healthcare Professional Communication (DHPC) on terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS) PDF, 448KB, File is accessible Date: 01. December 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: terlipressin

Terlipressin may cause severe or lethal respiratory failure in patients with hepatorenal syndrome type 1 (HRS-1) with a higher frequency than previously known, as well as increase the risk of sepsis or septic shock.

Medicines containing nomegestrol or chlormadinone: risk of meningioma Date: 24. November 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: nomegestrol- and chlormadinone-containing medicines

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission C(2022) 7954 (final) of 28.10.2022 with a notice in the national graduated plan procedure, dated 22 November 2022.