BfArM - Federal Institute for Drugs and Medical Devices

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1,024 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.

Official Launch of Iris Version 6 Date: 20. November 2025 Topics: Kodiersysteme Type: News

Please save the date for the launch webinar on January 28, 2026, at either 10:00 CET or 17:00 CET.

Direct Healthcare Professional Communication (DHPC) on Phenhydan solution for injection: risk of visual particles, use of a particle filter PDF, 185KB, File does not meet accessibility standards Date: 07. November 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: phenytoin sodium

The company Desitin Arzneimittel GmbH informs about a possible quality defect of the medicinal product Phenhydan solution for injection.

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 …

Iris version 6 is available for ICD-11 mortality coding Date: 04. November 2025 Topics: Kodiersysteme Type: News

The Iris software has been used for ICD-10 mortality coding for more than 20 years. Now, Iris is also available for ICD-11 mortality coding.

Direct Healthcare Professional Communication (DHPC) on caspofungin: Avoid use of polyacrylonitrile membranes during continuous renal replacement therapy. PDF, 147KB, File is accessible Date: 09. October 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: caspofungin

The marketing authorisation holders of caspofungin containing medicines would like to inform that during treatment with caspofungin the use of polyacrylonitrile membranes during continuous renal replacement therapy should be avoided.

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.

Direct Healthcare Professional Communication (DHPC) on finasteride und dutasteride: New measures to minimise the risk of suicidal thoughts PDF, 252KB, File does not meet accessibility standards Date: 15. September 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: finasteride, dutasteride

The marketing authorisation holders of finasteride- and dutasteride-containing medicinal products provide information on suicidal thoughts as an adverse drug reaction of orally administered finasteride-containing products.

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.

Direct Healthcare Professional Communication (DHPC) on Isozid 0.5 N powder for solution for infusion: Visual particles, use of a particle filter PDF, 230KB, File does not meet accessibility standards Date: 10. September 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isoniazid

Esteve Pharmaceuticals GmbH has issued a warning about visible particles in batch 286490A of the medicinal product Isozid 0.5 N powder for solution for infusion after reconstitution.

Direct Healthcare Professional Communication (DHPC) on Clozapine: Revised recommendations for routine blood count monitoring with regard to the risk of agranulocytosis PDF, 188KB, File is accessible Date: 08. September 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: clozapine

The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.

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 Lipidem emulsion for infusion: Subvisual agglomerates, use of an infusion filter for lipid emulsions PDF, 161KB, File does not meet accessibility standards Date: 29. August 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: soya bean oil, refined, medium-chain triglycerides, omega-3-acid triglycerides

Braun Melsungen AG informs about agglomerates consisting of droplet-like structures that have been detected in individual batches of the medicinal product.

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.

Direct Healthcare Professional Communication (DHPC) on Evrysdi 0,75 mg/ml powder for oral solution: Omission of mandatory labelling statement PDF, 141KB, File does not meet accessibility standards Date: 21. August 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: risdiplam

The marketing authorization holder Roche Registration GmbH informs about the omission of a mandatory labelling statement on the bottle labels, product carton, summary of product characteristics and Instruction for
Constitution.

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.

Radiation applications in combined clinical trials (clinical trials submitted to both CTIS and DMIDS) Date: 14. July 2025 Type: News

For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.

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.

New version of the DMIDS module "Clinical investigations and performance studies" from July 1, 2025 Date: 24. June 2025 Topics: Medical devices Type: News

The BfArM launches a new version of the DMIDS module "Clinical investigations and performance studies" on July 1, 2025.

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.

New radiation protection regulations effective July 1, 2025 Date: 20. June 2025 Type: News

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

Notification procedure pursuant to Section 32 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial …

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 …

Save the date – next Iris webinar Date: 05. June 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 9th July 2025.

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.

Direct Healthcare Professional Communication on Opzelura 15 mg/g cream: Important information regarding presence of particles in Opzelura cream PDF, 154KB, File does not meet accessibility standards Date: 24. April 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ruxolitinib phosphate

The company Incyte Biosciences Distribution B.V. informs about possible particles in Opzelura 15 mg/g cream, which may form during production from the active substance.