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

442 results

Results per page: 10 20 30

Dear Doctor Letter (Rote-Hand-Brief) on Myfortic® (mycophenolate): Serious risk of teratogenicity – reinforced advice on pregnancy prevention for women and men PDF, 180KB, File is accessible Date: 01. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate sodium

The company Novartis Pharma AG is circulating information in a Dear Doctor Letter that the advice regarding pregnancy prevention when using Myfortic® has been reinforced considerably.

Dear Doctor Letter (Rote-Hand-Brief) on Fingolimod (Gilenya®): Risks related to the effects on the immune system PDF, 1MB, File is accessible Date: 20. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on recent product information changes in relation to immunosuppressive effects.

Dear Doctor Letter (Rote-Hand-Brief) on Tarceva® (erlotinib): Restriction of indication PDF, 85KB, File is accessible Date: 14. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: erlotinib

The company Roche Pharma AG is circulating a Dear Doctor Letter with information on restrictions regarding the indications of Tarceva®.

Dear Doctor Letter (Rote-Hand-Brief) on Ampicillin+Sulbactam-ratiopharm® 1000/500 mg p.i. vials and Ampicillin+Sulbactam-ratiopharm® 2000/1000 mg p.i. vials: New information for use PDF, 133KB, File is accessible Date: 08. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ampicillin, sulbactam

The company Ratiopharm GmbH is circulating information that as a precautionary measure it is currently absolutely necessary to use a particle filter when administering the product.

Dear Doctor Letter (Rote-Hand-Brief) on Viekirax® (ombitasvir, paritaprevir, ritonavir) with or without Exviera® (dasabuvir): Important new safety information regarding liver function PDF, 444KB, File is accessible Date: 04. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ombitasvir, paritaprevir, ritonavir, dasabuvir

The company AbbVie Deutschland GmbH is circulating information on measures to reduce the risk of liver damage.

Information letters on Insuman® Basal and Insuman® Comb 25 - suspension for injection in 3-ml cartridges and Solo-Star® in pre-filled pens: Shortage Date: 01. December 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin human

The company Sanofi-Aventis Deutschland GmbH is sending out letters with the information that as of December 2015 the medicinal products Insuman® Basal and Insuman® Comb 25 will not be available at all or only limitedly due to capacity issues …

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): New measures to reduce the risk of progressive multifocal leukoencephalopathy PML - enhanced monitoring and stopping rules PDF, 715KB, File is accessible Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on important new measures to minimise the risk of progressive multifocal leukoencephalopathy (PML) during treatment with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on Fumaderm® initial / Fumaderm® (fumaric acid ester): Measures to reduce the risk of progressive multifocal leukoencephalopathy (PML)
PDF, 713KB, File is accessible
Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid ester

After a hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II and conclusion of the variation worksharing procedure, the company Biogen Idec GmbH is circulating information on measures to reduce the risk of progressive …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene® (Thalidomide): Reduction of starting dose when combined with melphalan in patients over 75 years of age PDF, 422KB, File is accessible Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Thalidomid

The company Celgene GmbH is circulating information that the starting dose of Thalidomide Celgene should be reduced when combined with melphalan and prednisone (MPT) in patients over 75 years of age with untreated multiple myeloma.

Dear Doctor Letter (Rote-Hand-Brief) on CellCept®: Serious risk of teratogenicity – strengthened advice on pregnancy prevention for women and men Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma is circulating information that the advice regarding pregnancy prevention when using CellCept® has been strengthened considerably.