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

448 results

Filter

Results per page: 10 20 30

Sorting:

Latest entries first

Relevance

Latest entries first(selected sorting)

Oldest entries first

Selected filter

Dear Doctor Letter (Rote-Hand-Brief) on TYGACIL® (tigecycline): Restrictions in all indications PDF, 44KB, File is accessible Date: 17. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tigecycline

Important information on restrictions in all indications of TYGACIL® (tigecycline) due to increased mortality observed in clinical trials.

Dear Doctor Letter (Rote-Hand-Brief) on ZERIT® (stavudine): Restricted indications PDF, 419KB, File is accessible Date: 09. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: stavudine

Important information on restrictions in the indications of ZERIT® (stavudine) due to potentially serious adverse reactions.

Dear Doctor Letter (Rote-Hand-Brief) on Anemet 100 mg i.v.® (dolasetron): Renunciation of marketing authorisation PDF, 90KB, File is accessible Date: 18. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the intravenous administration of dolasetron to adults for treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced this marketing …

Dear Doctor Letter (Rote-Hand-Brief) on Vigil® (modafinil): Restricted indication and important safety information PDF, 104KB, File is accessible Date: 11. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: modafinil

A safety review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has lead to a restriction of the indications of Vigil® (modafinil) to adults with excessive sleepiness associated with …

Dear Doctor Letter (Rote-Hand-Brief) on Octenisept® (octenidine hydrochloride, phenoxyethanol): Swelling and tissue damage following irrigation under pressure PDF, 2MB, File is accessible Date: 27. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: octenidine hydrochloride, phenoxyethanol

Warning against incorrect use of Octenisept®.

Dear Doctor Letter (Rote-Hand-Brief) on Dianeal®, Extraneal®, Nutrineal®: Risk of occurrence of aseptic peritonitis
 PDF, 44KB, File is accessible Date: 26. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peritoneal dialysis solutions

New information on the possible presence of endotoxins in batches of the peritoneal dialysis solutions Dianeal®, Extraneal®, and Nutrineal® and the associated increased risk of occurrence of aseptic peritonitis.

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): Severe liver injury
 PDF, 146KB, File is accessible Date: 24. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

Important safety-relevant information on the occurrence of severe liver injury and on necessary control tests.

Dear Doctor Letter (Rote-Hand-Brief) on Cubicin® (daptomycin): Cases of eosinophilic pneumonia
 PDF, 2MB, File is accessible Date: 21. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: daptomycin

Important safety information on the connection between Cubicin® (daptomycin) and eosinophilic pneumonia.

Dear Doctor Letter (Rote-Hand-Brief) on Vistide® (cidofovir): Serious adverse reactions following off-label use
 PDF, 145KB, File is accessible Date: 13. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cidofovir

Call for reporting of all suspected cases of adverse drug reactions in association with the use of Vistide®.

Dear Doctor Letter (Rote-Hand-Brief) on Dianeal®, Extraneal®, Nutrineal®: Risk of occurrence of aseptic peritonitis PDF, 65KB, File is accessible Date: 27. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peritoneal dialysis solution

Increased endotoxin concentrations which lead to an increased risk of occurrence of aseptic peritonitis have been found in batches of the peritoneal dialysis solutions Dianeal®, Extraneal® and Nutrineal®.