BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

105 results

Results per page: 10 20 30

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.

Dexamethasone: review of dexamethasone for treating adults with COVID-19 requiring respiratory support Date: 18. September 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dexamethasone

The European Medicines Agency (EMA) supports the use of dexamethasone in COVID-19 patients on oxygen or artificial respiration.

Leuprorelin-containing depot medicinal products: handling errors with depot formulations Date: 06. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: leuprorelin

With its decision of 29 July 2020, the BfArM implements the unanimous decision of the CMDh of 25 June 2020 for depot drugs containing leuprorelin.