BfArM - Federal Institute for Drugs and Medical Devices

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922 results

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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

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.

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.

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 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.

Non-exhaustive list of multidrug-resistant bacteria and criteria for classification of an antibiotic as a reserve antibiotic according to § 35a para. 1 SGB V (as of 4 August 2025) PDF, 316KB, File does not meet accessibility standards Date: 04. August 2025 Type: Download

Reserve antibiotics: Exemption from the benefit assessment by standardized criteria according to §35A social code book (SGB) V

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