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

66 results

Results per page: 10 20 30

New version of Iris version 6 is available for testing with ICD-11 Date: 16. December 2024 Topics: Kodiersysteme Type: News

The second test version of Iris version 6 for ICD-11 mortality coding has been released. You will find version 6.0.26 and the Iris Manual under “Downloads” on our website.

Direct Healthcare Professional Communication (DHPC) on metamizole-containing medicines: Important measures to minimise the serious outcomes of known risk of agranulocytosis PDF, 234KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products provide information on the early symptoms of agranulocytosis.

Ocaliva: Review of the risk-benefit ratio Date: 09. December 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: obeticholic acid

On 26 November 2024, the General Court dismissed the action for interim measures, which means that the revocation decision for Ocaliva has now taken effect.

Direct Healthcare Professional Communication (DHPC) on Cyanokit 5 g powder for solution for infusion: Potential microbial contamination of certain batches PDF, 214KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxycobalamin

The company SERB SA informs about a potential microbial contamination and a possible resulting risk of infection.

As a manufacturer of medical devices, what do I have to bear in mind when I want to launch a new medical device on the German market? Date: 04. December 2024 Topics: Medical devices Type: FAQ

Basic information on getting started in the medical device field and launching medical devices is explained at Basic information.

The monitoring of the manufacture, placing on the market and circulation of medical devices (including their operation …

We are a foreign manufacturer of medical products and would like to market our medical products in Germany as well. Is our CE mark also valid in Germany? Date: 04. December 2024 Topics: Medical devices Type: FAQ

If you have a CE mark for your medical product that is valid for the European market, you can also market the product in Germany.

More information:

FAQ: Do distributors or importers have to notify the distribution of medical devices that are …

We are manufacturers of medical products and require export certificates. Can you provide us with these? Date: 04. December 2024 Topics: Medical devices Type: FAQ

Many countries, such as Colombia or Pakistan, allow the marketing of products that have already been approved for the European market. Therefore, manufacturers must be able to prove that their products can be legally marketed there. These …

Save the date – next Iris webinar Date: 26. November 2024 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 11th December 2024.

Information letter on Airbufo Forspiro 160 µg/4,5 mg and 320 µg/9 mg: Possible failure of dose delivery from the first use PDF, 151KB, File does not meet accessibility standards Date: 22. November 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: budesonide and formoterole

The company Sandoz GmbH informs about a possible failure of dose delivery in several batches of Airbufo Forspiro.