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

Results per page: 10 20 30

Information Letter on Vfend®: possible occurrence of squamous cell carcinomas of the skin PDF, 370KB, File is accessible Date: 27. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

Important safety-relevant information on the potential risk of the occurence of squamous cell carcinomas of the skin in patients taking Vfend® (voriconazole) as long-term treatment.

Anti-diabetics containing rosiglitazone: Order of discontinuation in Germany due to cardiovascular risks and Dear Doctor Letter (Rote-Hand-Brief) PDF, 238KB, File is accessible Date: 24. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rosiglitazone

In a decision dated 23 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the recall of anti-diabetics containing rosiglitazone from the trade chain in Germany down to the pharmacy level. Due to the necessity …

Information Letter on VFEND® PDF, 370KB, File is accessible Date: 23. September 2010 Topics: Pharmakovigilanz Type: Download

Acive substance: voriconazole

(Summary of Product Characteristics)

Main information on: Omniscan®, OptiMARK®, Magnevist®, MultiHance®, Primovist®, Vasovist®, Gadovist®, ProHance®, Dotarem® PDF, 44KB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Download

Active substances: gadodiamide, gadoversetamide, gadopentetacid, gadobenacid, gadoxeracid, gadofosveset, gadobutrol, gadoteridol, gadoteracid

Information Letter regarding Relistor®: Occurrence of gastrointestinal perforations PDF, 2MB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methylnaltrexone bromide

Important safety information on the occurrence of gastrointestinal perforations in patients who received RELISTOR® (active substance: methylnaltrexone bromide) for subcutaneous injection.
An information letter including the Fachinformation

Main information on contrast media containing gadolinium: Risk of nephrogenic systemic fibrosis (NSF) PDF, 44KB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

Summarising information on the risk of nephrogenic systemic fibrosis in association with the administratiion of gadolinium-containing contrast media.

Information Letter on Relistor® PDF, 2MB, File is accessible Date: 10. September 2010 Topics: Pharmakovigilanz Type: Download

Active Substance: methylnaltrexonbromide

(Summary of Product Characteristics)

Hormone Replacement Therapy (HRT): duration of gestagen addition in sequential HRT Date: 10. September 2010 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gestagen

In a Notice (Bescheid) of 23 August 2010 relating to medicinal products for sequential HRT with gestagen addition on less than 12 days per treatment cycle, the BfArM ruled that the product information be supplemented. It is stated that there …

Angiotensin-receptor-antagonists: BfArM and EMA are assessing studies on the risk of cancer. Date: 13. August 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: angiotensin-receptor-antagonists

In June 2010 “Lancet Oncology“ published the results of a meta-analysis (Sipahi et al., 2010), in which the authors observed a slightly increased risk for new cases of cancer under angiotensin-receptor-antagonist therapies.

Dear Doctor Letter on Xyrem®: Risk of dosing errors PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium oxybate

Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused.

Rote-Hand-Brief on Xyrem® PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Download

Active substance: sodium oxybate

Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations PDF, 58KB, File is accessible Date: 09. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoprofen

Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen.

Rote-Hand-Brief on Ketoprofen
PDF, 58KB, File is accessible
Date: 05. August 2010 Topics: Pharmakovigilanz Type: Download

Active substance: ketoprofene

Rote-Hand-Brief on Cardioxane® PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: dexrazoxane

Dear Doctor letter (Rote Hand Brief) on Cardioxane®: Secondary neoplasia in children PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children.

Rosiglitazone: The BfArM and the EMA emphasise restrictions in indications Date: 23. July 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: rosiglitazone

In July 2010 the CHMP at the EMA initiated assessment of new study results on the antidiabetic, rosiglitazone. The BfArM, like the CHMP, is repeating the advice that the long-existing restrictions in rosiglitazone indications should be …

Rosiglitazone: The EMA initiates assessment of new study results Date: 16. July 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: rosiglitazone

In July 2010 the CHMP at the EMA is assessing the recently published new study results on rosiglitazone (June 2010).

Rote-Hand-Brief on Invirase® PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: saquinavir

Dear Doctor letter on Invirase®: QT-prolongations PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir).

Rote-Hand-Brief on Perfalgan® PDF, 1MB, File is accessible Date: 14. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: paracetamol

Dear Doctor Letter on Perfalgan®: Inadvertent overdose in newborn babies and infants PDF, 1MB, File is accessible Date: 14. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paracetamol i.v.

Important information on the risk of inadvertently overdosed intravenous infusion of paracetamol 10 mg/ ml to newborn babies and infants.

Rote-Hand-Brief on Temozolomid Hospira® PDF, 146KB, File is accessible Date: 12. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: temozolomide

Dear Doctor Letters on temozolomide: Recall Date: 09. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

For precautionary reasons the pharmaceutical companies will recall certain batches of temozolomide.

Rote-Hand-Brief on Temozolomid Hexal® PDF, 307KB, File is accessible Date: 09. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: temozolomide

Valproic acid/valproate: interaction with carbapenem Date: 17. June 2010 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproic acid

The product information texts on all valproic acid or products containing valproates should include warnings about clinically relevant interactions with carbapenems (decreased valproate plasma concentration) to come up to the latest findings. …

Bufexamac-containing products for topical use Date: 05. May 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: bufexamac

A two-year period for selling bufexamac-containing products cannot be granted according to BfArM’s Feststellungsbescheid (ascertainment decision). Prior to the BfArM order the authorisation holders had abandoned their marketing authorisations …

Information Letter on Exelon® and Prometax® PDF, 97KB, File does not meet accessibility standards Date: 30. April 2010 Topics: Pharmakovigilanz Type: Download

Active substance: rivastigmine

Information Letter on Exelon® and Prometax® transdermal patches: incorrect administration and medication error PDF, 51KB, File is accessible Date: 29. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rivastigmine

In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported.

Bufexamac products for topical use: Revocation of authorisations in the EU because of unfavourable benefit-risk ratio Date: 27. April 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: bufexamac

Assessment of medicinal products containing bufexamac for topical use in the authorised indications has revealed a negative overall benefit-risk ratio. Therefore the authorisations are revoked

Rote-Hand-Brief on Kepivance® PDF, 2MB, File does not meet accessibility standards Date: 20. April 2010 Topics: Pharmakovigilanz Type: Download

Active substance: palifermin