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

Dear Doctor Letter (Rote-Hand-Brief) on transdermal patches containing fentanyl: Possible life-threatening consequences of accidental exposure PDF, 1MB, File is accessible Date: 13. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

The marketing authorisation holders are circulating information on possible life-threatening consequences of accidental exposure to patches containing fentanyl.

Information Letter on Procoralan®: Potentially dangerous bradycardia PDF, 1MB, File is accessible Date: 11. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH has issued a reminder that specific conditions for use must be observed in order to avoid potentially dangerous bradycardia when administering the medicinal product Procoralan® containing ivabradine for …

Dear Doctor Letter (Rote-Hand-Brief) on Invirase® (saquinavir): Important new safety information on ECG monitoring PDF, 467KB, File is accessible Date: 28. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

The company Roche Pharma AG is circulating information on new recommendations regarding ECG monitoring in treatment-naïve patients receiving Invirase® (saquinavir). This Dear Doctor Letter is intended to emphasise the necessity of ECG

Dear Doctor Letter (Rote-Hand-Brief) on Norditropin® SimpleXx® 10 mg/1.5 ml: Counterfeit PDF, 2MB, File is accessible Date: 23. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

The company Novo Nordisk Pharma GmbH is circulating information on the discovery of a counterfeit cartridge of the medicinal product Norditropin® SimpleXx® 10 mg/1.5 ml (active substance: somatropin).

Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 300KB, File is accessible Date: 09. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dihydroergotoxine: Restriction of indications PDF, 99KB, File is accessible Date: 27. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dihydroergotoxine

The company Sigma-Tau Arzneimittel GmbH is circulating information that there are several indications for which medicinal products with the active substance dihydroergotoxine must no longer be prescribed in the future.

Granocyte® (lenograstim): Risk of capillary leak syndrome PDF, 309KB, File is accessible Date: 20. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenograstim

The company Chugai Pharma Marketing is circulating information on the occurrence of capillary leak syndrome (CLS) following administration of lenogastrim (as also in the case of other G-CSF products) in patients undergoing chemotherapy, as …

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication and recommendations for controls during administration PDF, 917KB, File is accessible Date: 11. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

The company Servier Deutschland GmbH is circulating information that use of Protelos is now restricted to the treatment of severe osteoporosis in postmenopausal women and adult men with a high risk of fractures who cannot be treated with other …

Information letter on Isotonic Saline Solution Baxter, Clear-Flex plastic containers with Emoluer valves: Recall due to leakage PDF, 91KB, File is accessible Date: 07. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isotonic saline

In addition to the safety information of 18 February 2014, the company Baxter Deutschland GmbH is circulating information on the recall of several batches of the medicinal product Isotonic Saline Solution Baxter.

Information Letter on Doribax® 250 mg/500 mg (doripenem): Discontinuation and recall of stock in circulation PDF, 647KB, File is accessible Date: 05. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: doripenem

The company Janssen-Cilag GmbH points out that it will discontinue distribution of the medicinal product Doribax® 250 mg/500 mg (active substance: doripenem). The entire stock still on the market will be recalled on pharmacy level. This recall …