BfArM - Federal Institute for Drugs and Medical Devices

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107 results

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Studies at Synchron Research Services, India: review with regard to the conduct of studies Date: 19. December 2022 Type: Risk Assessment Procedures

Active substance: various

The Federal Institute for Drugs and Medical Devices (BfArM) implements the EU Commission's implementing decision of 28.11.2022 nationally by notice of 13 December 2022.

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.

Rubraca® (rucaparib camsylate): cancer drug review based on preliminary study results Date: 30. September 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: rucaparib camsylate

With the publication of the European Commission Decision on 21 September 2022, the Risk Assessment Procedure under Article 20 of Regulation (EC) No 726/2004 concerning "Rubraca - Rucaparib" was finalised.

Dihydroergotamine and dihydroergotoxine: unfavourable risk-benefit ratio Date: 11. March 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dihydroergotamine | dihydroergotoxine

In a notice dated 15. January 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled further suspension of marketing authorisation until 01. February 2020

Tetrazepam-containing medicines: revocation of approval Date: 19. July 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: tetrazepam

Marketing authorizations for tetrazepam-containing drugs are being revoked because the risk-benefit ratio is unfavorable.

Ifosfamide: review of encephalopathy risk Date: 23. April 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ifosfamide

The CMDh, having considered the PRAC assessment report and recommendation, agreed by majority that the benefits of ifosfamide solutions for infusion continue to outweigh their risks in the treatment of different types of cancers, including various …

Ulipristal acetate 5 mg: temporary suspension of marketing authorisation for medicinal products for the treatment of uterine fibroids Date: 02. February 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ulipristal acetate

The Federal Institute for Drugs and Medical Devices (BfArM) has revoked the provisional suspension of the marketing authorisations for medicinal products and ordered changes to the marketing authorisations.

Retinoids: updated measures for pregnancy prevention as well as warnings on neuropsychiatric disorders after oral use Date: 07. January 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: acitretin | adapalene | alitretinoin | bexarotene | isotretinoin | tazarotene | tretinoin

The BfArM requires pharmaceutical companies to report annually all pregnancies reported in connection with the use of acitretin, alitretinoin and isotretinoin.

Panexcell Clinical Laboratories Priv. Ltd.: conduct of studies in India Date: 14. October 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: vgarious (in Germany parenteral iron sucrose)

The BfArM has provisionally ordered the suspension of the above-mentioned generic drug approvals in its decision of October 7, 2020.

Ranitidine: EMA reviews ranitidine-containing drugs based on detection of NDMA Date: 29. September 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ranitidine

The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the temporary suspension of all holders of marketing authorisations for medicinal products containing ranitidine.