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

Results per page: 10 20 30

Selected filter

Anapen® solution for injection 300 μg adrenaline in 0.3 ml solution for injection, pre-filled syringe / Anapen® Junior 150 μg adrenaline in 0.3 ml solution for injection, pre-filled syringe by Lincoln Medical Limited (adrenaline): Recall of all batches on patient level PDF, 103KB, File is accessible Date: 06. June 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: adrenaline

Lincoln Medical Limited is recalling all unexpired units of the a.m. medicinal product because of the risk of failure to deliver the adrenaline solution in an anaphylactic emergency situation.

Adenuric® (febuxostat): Risk of hypersensitivity reactions including Stevens-Johnson Syndrome and acute anaphylactic reaction/shock PDF, 113KB, File is accessible Date: 22. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: febuxostat

Serious hypersensitivity reactions have been reported under treatment with Adenuric®. In most of the cases these reactions occurred during the first month of treatment with febuxostat.

Information Letter on Protopic® (tacrolimus): Recommendations for the correct use PDF, 625KB, File is accessible Date: 11. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tacrolimus

Important recommendations for the correct use of Protopic® (0.03% and 0.1%) Ointment in order to minimise risks, especially when treating children.

ViaSpan® organ preservation solution: Extended information on possible contamination of product during the manufacture PDF, 168KB, File is accessible Date: 10. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: organ preservation solution

Since alternative products are licensed in Germany, all potentially contaminated batches of ViaSpan® were recalled in Germany. In cases in which an infection with Bacillus cereus is suspected, the following information on the resistance …

Dear Doctor Letter (Rote-Hand-Brief) on Atorvastatin Basics film-coated tablets ® (atorvastatin): Recall of all batches of the medicinal product currently in circulation PDF, 271KB, File is accessible Date: 03. May 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: atorvastatin

The maximum daily dose for children (point 3 of the Package Leaflet) is incorrectly stated as "maximum dose of 80 mg once daily" instead of "maximum dose of 20 mg once daily".

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Update on the recommendation for cardiovascular monitoring at the beginning of treatment PDF, 352KB, File is accessible Date: 30. April 2012 Topics: Presse Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Important additional recommendations regarding a more intense monitoring of cardiovascular functions at the beginning of treatment with Gilenya® (fingolimod) in patients with relapsing-remitting multiple sclerosis.

Dear Doctor Letter (Rote-Hand-Brief) on Carbopaltin onkovis® 10 mg/ml concentrate for solution for infusion (carboplatin): Possible crystallisation of the active substance PDF, 85KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

Due to the danger of a substance-specific crystallisation of the active substance, the solution must be examined for the absence of particles and turbidity prior to use.

Dear Doctor Letter (Rote-Hand-Brief) on Carbomedac® 10 mg/ml concentrate for solution for infusion (carboplatin): Possible crystallisation of the active substance PDF, 45KB, File is accessible Date: 19. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

Due to the danger of a substance-specific crystallisation of the active substance, the solution must be examined for the absence of particles and turbidity prior to use.

Dear Doctor Letter (Rote-Hand-Brief) on Alimta® (pemetrexed): Batch recall PDF, 332KB, File is accessible Date: 10. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pemetrexed

Alimta® 500 mg batches recalled due to a possible microbial contamination with Methylobacterium sp. which was discovered during routine controls. In Germany, this concerns batch A931727G and certain imported batches.

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): New contraindications PDF, 2MB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

The pharmaceutical entrepreneur is sending out information on new contraindications and warnings for the use of Protelos® (strontium ranelate). These changes also apply to Osseor®.