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05.06.2025
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Events and trainings
Events and trainings
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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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04.06.2025
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Urgent Field Safety Notice for Acurate neo2 and Prime Aortic Valve System by Boston Scientific Corporation Marlborough
Product group Non-active implants -
cardiac surgery
Reference 38522A/24
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04.06.2025
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Urgent Field Safety Notice for STA - Owren-Koller by Stago Frankreich
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 19862/25
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04.06.2025
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Urgent Field Safety Notice for Collection Red cell LCR filter set by MacoPharma S.A.
Product group Injections / Infusions / Transfusions / Dialysis -
equipment for collecting blood products and peripheral stem cells
Reference 20744/25
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04.06.2025
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Information Iris Webinar - July 2025
Information Iris Webinar - July 2025
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04.06.2025
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From learner to teacher – PharmTrain Fellows prepare for their own training courses
From learner to teacher – PharmTrain Fellows prepare for their own training courses
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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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03.06.2025
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Mysimba: Potential long-term cardiovascular risk
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).
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03.06.2025
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Drug allergies, cutaneous adverse drug reactions and dedicated pharmacovigilance questions
Added information about the new project KIAM - AI-based expression analysis of marker genes for the in vitro detection of drug sensitization
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02.06.2025
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Urgent Field Safety Notice for DeepUnity PACSonWEB by DH Healthcare GmbH
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
Reference 13207/25
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02.06.2025
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Urgent Field Safety Notice for Optima Coil System by BALT USA LLC
Product group Non-active implants -
special implants
Reference 19531/25
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02.06.2025
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Urgent Field Safety Notice for Centricity High Acuity (CHA) C.C and Anesthesia by GE Healthcare Finland Oy
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 20286/25
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02.06.2025
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Urgent Field Safety Notice for MiTF, (C5 & D5) by Bio S., Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 20792/25
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02.06.2025
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Urgent Field Safety Notice for Alinity i Total PSA Reagent Kit by Abbott Ireland Diagnostics Division
Product group In-vitro diagnostics -
immunological products
Reference 22126/25
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28.05.2025
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Urgent Field Safety Notice for Fujifilm Synapse PACS by FUJIFILM Medical System U.S.A., Inc.
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
Reference 10938/25
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28.05.2025
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Urgent Field Safety Notice for Copeland Fetal Scalp Electrode by Rocket Medical plc
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 20695/25
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28.05.2025
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Urgent Field Safety Notice for INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE by Wilson-Cook Medical, Inc
Product group Medical instruments for use in humans -
general instruments
Reference 18733/25
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28.05.2025
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Urgent Field Safety Notice for LifePearl microspheres by MicroVention Europe
Product group Non-active implants -
special implants
Reference 23292/25
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28.05.2025
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German SAE Report Form
Report form for reporting of serious adverse events (SAE) in clinical trials or performance studies for use by sponsors according to § 3 (5) of the Ordinance on Medical Devices Vigilance
PDF-Form (use of Adobe Acrobat 9.X recommended)
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