BfArM - Federal Institute for Drugs and Medical Devices

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1,043 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.

Information Iris Webinar - January 2026 PDF, 129KB, File is accessible Date: 20. November 2025 Type: Download

Information Iris Webinar - January 2026

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.

Structure of the BfArM in text form PDF, 172KB, File is accessible Date: 05. November 2025 Topics: About BfArM Type: Download

Structure

Structure of the BfArM PDF, 135KB, File does not meet accessibility standards Date: 05. November 2025 Topics: About BfArM Type: Download

Structure

Iris User Manual V6.1.0.9S1 - track changes PDF, 5,42 MB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

Iris User Manual V6.1.0.9S1 - track changes

Iris User Manual V6.1.0.9S1 PDF, 4,41 MB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

Iris User Manual V6.1.0.9S1

User Interface English V6.1.0-Y2025S1 ZIP, 14 kB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

User Interface English V6.1.0-Y2025S1

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

Downloads Iris Institute - Terms and conditions for downloading (PDF, 244 kB) PDF, 244KB, File is accessible Date: 17. October 2025 Topics: Kodiersysteme Type: Download

Downloads Iris Institute - Terms and conditions for downloading

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.

Comments concerning texts published in Issue 12.2 PDF, 329KB, File does not meet accessibility standards Date: 01. October 2025 Topics: Licensing Type: Download

Comments concerning texts published in Issue 12.2

Causes of death coding in Iris with ICD-11 testing results PDF, 207KB, File is accessible Date: 22. September 2025 Type: Download

Causes of death coding in Iris with ICD-11 testing results

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.