BfArM - Federal Institute for Drugs and Medical Devices

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435 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

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

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

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.

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.

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

Guidance for Applicants Scientific Advice PDF, 311KB, File is accessible Date: 15. July 2025 Topics: About BfArM Type: Download

Guidance for Applicants Scientific Advice

Presenation Iris Webinar July 2025 PDF, 411KB, File does not meet accessibility standards Date: 09. July 2025 Topics: Kodiersysteme Type: Download

Presenation Iris Webinar July 2025

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.

Information Iris Webinar - July 2025 PDF, 137KB, File is accessible Date: 04. June 2025 Topics: Kodiersysteme Type: Download

Information Iris Webinar - 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.

Agenda Iris User Group Meeting PDF, 141KB, File is accessible Date: 20. May 2025 Topics: Kodiersysteme Type: Download

Agenda Iris User Group Meeting

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.

Directions to BfArM PDF, 349KB, File does not meet accessibility standards Date: 15. May 2025 Topics: About BfArM Type: Download

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