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

818 results

Filter

Results per page: 10 20 30

Sorting:

Latest entries first

Relevance

Latest entries first(selected sorting)

Oldest entries first

Selected filter

Faecal microbiota transplantation (FMT, stool transplantation): Risk of transmission of multi-resistant bacteria Date: 18. June 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: FMT

The American Food and Drug Administration (FDA) warns of the risk of serious bacterial infections caused by the transmission of multi-resistant bacteria during faecal microbiota transplants (FMT).

Omega-3 fatty acids: EMA reviewing use after heart attacks Date: 18. June 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: omega-3 fatty acids

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the implementing decision of the European Commission in its notification of 14 June 2019.

Fenspiride-containing drugs: potential risk of cardiac arrhythmia Date: 06. June 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fenspirid

The PRAC recommendation was adopted by the CMDh by consensus and will be implemented directly at national level.

Dear Doctor Letter (Rote-Hand-Brief) on Xeljanz® (tofacitinib): restriction of 10 mg twice-daily use in patients who are at high risk for pulmonary embolism PDF, 294KB, File is accessible Date: 28. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer Europe would like to inform you that the European Medicines Agency (EMA) is reviewing the benefits and risks of Xeljanz® (tofacitinib) in all authorised indications.

Dear Doctor Letter (Rote-Hand-Brief) on Eliquis®, Pradaxa®, Lixiana®/Roteas® and Xarelto®: use is not recommended in patients with antiphospholipid syndrome PDF, 1MB, File is accessible Date: 23. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apixaban | dabigatran etexilate | edoxaban | rivaroxaban

Marketing authorisation holders inform that the use of direct oral anticoagulants (DOACs) in patients with antiphospholipid syndrome is not recommended.

Dear Doctor Letter (Rote-Hand-Brief) on Tyverb® (lapatinib): important update to Summary of Product Characteristics PDF, 872KB, File is accessible Date: 17. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Lapatinib

Novartis will provide information on changes with regard to the therapeutic indication (Section 4.1) of the Lapatinib Summary of Product Characteristics.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing biotin: risk of false laboratory test results due to biotin interferences PDF, 213KB, File is accessible Date: 15. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: biotin

Taking medicinal products, dietary supplements or dietary food for special medical purposes is associated with a risk of false positive or false negative laboratory test results.

Dear Doctor Letter (Rote-Hand-Brief) on modafinil: potential risk of severe congenital malformations PDF, 762KB, File is accessible Date: 09. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: modafinil

In coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of medicinal products containing modafinil inform about new findings related to the use of modafinil during pregnancy.

Fluoroquinolones: severe and long-lasting side effects in muscles, joints and nervous system Date: 02. May 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fluoroquinolones | quinolones

In response to enquiries, the BfArM refers at this point to Annex II of the Commission Decision, which describes areas of application in Category 1.

Lapatinib (Tyverb®): Re-analysis of data on use following treatment with trastuzumab Date: 30. April 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: lapatinib

The European Medicines Agency (EMA) is updating the prescribing information for Tyverb® (lapatinib) after irregularities had been observed in results of a study involving postmenopausal women.