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15.09.2025
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Direct Healthcare Professional Communication (DHPC) on finasteride und dutasteride: New measures to minimise the risk of suicidal thoughts
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.
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12.09.2025
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Azithromycin: Re-evaluation of the benefits and risks
Active substance: azithromycin
The European Commission's final decision on the risk assessment procedure for azithromycin has been published.
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12.09.2025
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Urgent Field Safety Notice for STA LIATEST DDI PLUS (IVDR Class C) by Diagnostica Stago
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 42894/25
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12.09.2025
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Urgent Field Safety Notice for Charging unit mounted W/T AC TS7500 by Baxter Medical Systems GmbH + Co. KG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 42068/25
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12.09.2025
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Urgent Field Safety Notice for RENZAN by MicroVention,INC.
Product group Non-active implants -
special implants
Reference 43167/25
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12.09.2025
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Urgent Field Safety Notice for MassCheck Dried Blood Spot Control Bi-Level I+II by Chromsystems Instruments & Chemicals GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 43400/25
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11.09.2025
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Urgent Field Safety Notice for Allura Xper, Allura CV20 by Philips Nordic
Product group Radiological technology -
radiological equipment for vascular diagnostics
Reference 42673/25
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10.09.2025
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Urgent Field Safety Notice for Getinge 88-series by Getinge Disinfection AB
Product group General equipment for medical treatment -
cleaning / disinfection / sterilisation
Reference 39788/25
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10.09.2025
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Urgent Field Safety Notice for FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 by Agilent Technologies Singapore
Product group In-vitro diagnostics -
immunological products
Reference 37144/25
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10.09.2025
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Urgent Field Safety Notice for Evolution Upgrade 1.5T, 3.0T; Ingenia 1.5T, 1.5T CX, 1.5T S. 3.0T, 3.0T CX, Ambition S. Ambition X, Elition S. Elition X; MR 5300, MR 7700; SmartPath to dStream for 1.5T, 3.0T, XR and 3.0T, Ingenia Elition X; Upgrade to MR 7700 by Philips Medical Systems Nederland B.V.
Product group Electromedical fields -
equipment for MR tomography
Reference 19824/25
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10.09.2025
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Direct Healthcare Professional Communication (DHPC) on Isozid 0.5 N powder for solution for infusion: Visual particles, use of a particle filter
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.
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09.09.2025
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Urgent Field Safety Notice for Kapillardrain by Primed Halberstadt Medizintechnik GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
drainages and suction systems
Reference 42682/25
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09.09.2025
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Urgent Field Safety Notice for SenTiva Generator Model 1000 by LivaNova, Inc
Product group Active implantable medical devices -
biostimulators
Reference 42764/25
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09.09.2025
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Urgent Field Safety Notice for Blueflow Venous Stent by Contract Medical International GmbH
Product group Non-active implants -
special implants
Reference 39103/25
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08.09.2025
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Direct Healthcare Professional Communication (DHPC) on Clozapine: Revised recommendations for routine blood count monitoring with regard to the risk of agranulocytosis
Active substance: clozapine
The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.
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08.09.2025
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Urgent Field Safety Notice for Indiko (ISE), Indiko Plus (ISE) by Thermo Fisher Scientific Oy
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 42064/25
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08.09.2025
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Urgent Field Safety Notice for Defigard HD-7 by Schiller Medical SAS
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 42108/25
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08.09.2025
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Urgent Field Safety Notice for Philips Allura Xper, Allura Centron, Allura CV20 by Philips Nordic
Product group Radiological technology -
radiological equipment for vascular diagnostics
Reference 42563/25
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08.09.2025
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Urgent Field Safety Notice for Liver Assist Perfusion Set by XVIVO B.V.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 41271/25
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08.09.2025
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Urgent Field Safety Notice for Fujifilm FDR Visionary Suite by Shimadzu Corporation
Product group Radiological technology -
stationary radiological equipment
Reference 41141/25
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