BfArM - Federal Institute for Drugs and Medical Devices

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647 results

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Promethazine: New contraindication for children under 6 years of age Date: 20. November 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: promethazine

The BfArM informs that the use of medicines containing promethazine is contraindicated in children under the age of 6 due to age-specific risks.

How can an acceleration or prioritisation of the assessment of a variation procedure be requested from BfArM, and what information is required? Date: 05. November 2025 Topics: Licensing Type: FAQ

Generally, applications are processed in the order in which they are received. Exceptions to this rule may be made in justified cases if this leads to an improvement in an existing critical supply situation or if it can avert a critical supply …

Oxbryta (voxelotor): EMA confirms suspension of sickle cell disease medicine Oxbryta Date: 23. October 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: voxelotor

EMA confirms suspension of sickle cell disease medicine Oxbryta

Finasteride- and dutasteride-containing medicines: Suicidal thoughts and behaviours Date: 16. September 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: finasteride, dutasteride

The Federal Institute for Drugs and Medical Devices (BfArM) implements the final decision of the EU Commission nationally.

Azithromycin: Re-evaluation of the benefits and risks Date: 12. September 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: azithromycin

The European Commission's final decision on the risk assessment procedure for azithromycin has been published.

Levamisole: Review of the risk of leukoencephalopathy Date: 05. September 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: levamisole

The European Medicines Agency (EMA) is initiating a safety review of medicines containing levamisole for the treatment of parasitic worm infections.

Direct Healthcare Professional Communication (DHPC) on Amversio 1 g powder for oral administration: Wrong PZN encoded in the 2D barcode PDF, 178KB, File does not meet accessibility standards Date: 22. August 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: betaine

SERB Pharmaceuticals has reported that three batches were packaged for the German market with a faulty PZN number in the NTIN-DE and in the 2D barcode.

Thalidomide, lenalidomide and pomalidomide: Requirements for the prescription in Germany Date: 06. August 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: thalidomide, lenalidomide, pomalidomide

The Federal Institute for Drugs and Medical Devices (BfArM) once again draws attention to the applicable safety regulations and the requirements for the proper prescription of thalidomide, lenalidomide and pomalidomide.

Information for marketing authorisation holders: Current information on submission for step 3 Date: 23. July 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

Information for marketing authorisation holders: Current information on submission for step 3

Are variations to purely national licences that contain only one single change but several marketing authorisations regarded as a grouping? Date: 03. July 2025 Topics: Licensing Type: FAQ

Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective notification …

Angusta (misoprostol for induction of labour): Reports of overdose and contraindicated use with labour already in progress Date: 27. June 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: misoprostol

Reminder of the authorisation-compliant application.

Sodium oxybate: Review of use in alcohol dependence Date: 23. June 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: sodium oxybate

The European Medicines Agency (EMA) is starting to review medicines containing sodium oxybate.

How are the data on antibiotic resistance in section 5.1 of the SmPC to be updated? Date: 10. June 2025 Topics: Licensing Type: FAQ

Data on the resistance situation of systemically available antibiotics in Germany is regularly reassessed in the Z.A.R.S. project and is considered in the resistance table for Section 5.1 of the SmPC.

The previously requested EUCAST table (European …

Mysimba: Potential long-term cardiovascular risk Date: 03. June 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: naltrexone, bupropion

EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation).

Ipidacrine: Review of efficacy in the authorised indications Date: 23. May 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: ipidacrin

The European Medicines Agency (EMA) is starting to review medicines containing ipidacrine.

Information letter on Toxogonin (obidoxime chloride) 250 mg/ml solution for injection: Change of storage conditions PDF, 132KB, File does not meet accessibility standards Date: 20. May 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: obidoxime chloride

The company SERB SA and the German co-distributor Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG inform about a change in the storage conditions of Toxogonin.

Is it allowed to register my trial in DRKS if it is already registered in another WHO Primary Registry (e.g. CTIS)? Date: 07. April 2025 Topics: About BfArM Type: FAQ

WHO recommends that clinical trials with one or more recruitment sites in the same country should be registered in only one study registry. For more information, please visit the WHO website.

If you still wish to register in the DRKS (e.g. because …

Metamizole-containing medicinal products: Risk of agranulocytosis - referral Date: 21. March 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: metamizole

With the publication of the European Commission's decision, the risk assessment procedure on the medicinal products containing metamizole has been completed.

How is the reference to the digital package leaflet implemented for centrally authorised medicinal products? Date: 17. February 2025 Topics: Licensing Type: FAQ

The European Medicines Agency (EMA) is the competent authority for centrally authorised medicinal products. The BfArM recommends to contact the EMA in case of questions.

Information letter on Kisqali 200 mg film tablets: Change to storage conditions and shelf life PDF, 164KB, File does not meet accessibility standards Date: 17. February 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: ribociclib

The company Novartis Pharma GmbH informs about a change to storage condtions and shelf life of Kisqali 200 mg film tablets.

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.

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 …

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.

Do distributors or importers have to notify the distribution of medical devices that are already registered in the European Economic Area in Germany? Date: 22. October 2024 Topics: Medical devices Type: FAQ

No. If a product is already CE-marked and registered in an EEA member state, it does not have to be notified in Germany in the German Medical Devices Information and Database System additionally.

Do importers have to register with DMIDS? Date: 22. October 2024 Topics: Medical devices Type: FAQ

Please refer to Article 13 of Regulation (EU) 2017/745 and Article 13 of Regulation (EU) 2017/746 for the general obligations of importers under the MDR and IVDR (effective date 26 May 2021 and 26 May 2022):

Laws and regulations

German importers …

What other obligations for importers arise from the MDR and IVDR? Date: 22. October 2024 Topics: Medical devices Type: FAQ

The general obligations of importers are described in Article 13 of the MDR and IVDR.

Please note that the BfArM has no responsibilities in this context. You can find the federal state authority responsible for your company here:

Landesbehörden …