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05.06.2025
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Save the date – next Iris webinar
The next Iris webinar will be held on 9th July 2025.
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23.06.2025
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Sodium oxybate: Review of use in alcohol dependence
Active substance: sodium oxybate
The European Medicines Agency (EMA) is starting to review medicines containing sodium oxybate.
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31.10.2025
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spec-ICD11-V2025S10
spec-ICD11-V2025S10
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31.10.2025
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spec-ICD11-V2025S10 PDF
spec-ICD11-V2025S10 PDF
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04.06.2025
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Statistics "Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)"
The following table gives an overview of the herbal, homeopathic and anthroposophic medicinal products with completed marketing authorisation or registration procedure which are available on the German market.
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08.12.2025
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Structure of the BfArM
Structure of the BfArM (date 08.12.2025)
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08.12.2025
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Structure of the BfArM in text form
Structure of the BfArM (date 08.12.2025)
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04.07.2025
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Submission of Variations
Aerosol dispensers containing fluorinated greenhouse gases, including medicinal metered dose inhalers, may only be placed on the market, supplied or made available to third parties in the EU from 1 January 2025 if they are labelled in accordance with Article 12(3) of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-Gas Regulation).
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29.10.2025
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Successful Regional Training on Bioequivalence Study Assessment Held in Nairobi
Successful Regional Training on Bioequivalence Study Assessment Held in Nairobi
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06.08.2025
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Thalidomide, lenalidomide and pomalidomide: Requirements for the prescription in Germany
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.
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15.12.2025
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Updated information Iris Webinar - January 2026
Updated information Iris Webinar - January 2026
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08.07.2025
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Urgent Field Safety Notice for 3mensio Workstation by Pie Medical Imaging B.V.
Product group Medical data processing (software) -
software for computer-based treatment
Reference 28334/25
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27.08.2025
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Urgent Field Safety Notice for 8-402 Atemtraining-Set by Flexicare Medical Limited
Product group Physical therapy -
insufflation technique
Reference 21354/25
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29.10.2025
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Urgent Field Safety Notice for 9180 Electrolyte Analyzer by Roche Diagnostics GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 49951/25
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20.11.2025
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Urgent Field Safety Notice for ACCELLA THERAPY STANDALONE MAT by Hill-Rom SAS
Product group General equipment for medical treatment -
furnishings
Reference 52192/25
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14.11.2025
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Urgent Field Safety Notice for Access 2 Reaction Vessel by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 54046/25
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29.07.2025
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Urgent Field Safety Notice for Access High Sensitivity Troponin I Reagent by Beckman Coulter Inc.
Product group In-vitro diagnostics -
immunological products
Reference 41368/24
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29.12.2025
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Urgent Field Safety Notice for Access Port Kit by Intuitive Surgical, Inc.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 60780/25
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08.09.2025
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Urgent Field Safety Notice for ACCOLADE, ACCOLADE MRI; ALTRUA; PROPONENT, PROPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 by Boston Scientific CRM
Product group Active implantable medical devices -
cardiac pacemakers
Reference 43752/24
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08.07.2025
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Urgent Field Safety Notice for Achieva 3.0T/XR, Evolution upgrade 1.5T/3.0T, Ingenia 1.5T/1.5T S/3.0T/3.0T CX/Ambition S/Ambition X/Elition S/Elition X/Intera 3.0T Quasar Dual, MR 5300, MR 7700, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0 by Philips Medical Systems Nederland B.V.
Product group Electromedical fields -
equipment for MR tomography
Reference 28689/25
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