BfArM - Federal Institute for Drugs and Medical Devices

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124 results

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Iris - Reported issues by users with answers from Iris Core Group zip, 28KB, File does not meet accessibility standards Date: 16. December 2024 Topics: Kodiersysteme Type: Download

Iris - Reported issues by users with answers from Iris Core Group

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 …