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12.12.2024
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Written renouncement
As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG (Medicines Products Act)“ are availabe via the portal PharmNet.Bund.
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12.12.2024
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Notification obligations of the marketing authorisation holder in accordance with Section 29 sub-section 1g AMG as of 28 October 2013
As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG (Medicines Products Act)“ are availabe via the portal PharmNet.Bund.
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12.12.2024
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Urgent Field Safety Notice for Accu-Chek Spirit 3.15 ml Plastic Cartridge by Roche Diabetes Care GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 41279/24
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12.12.2024
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Urgent Field Safety Notice for MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP by Baxter Healthcare SA
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 37287/24
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12.12.2024
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Urgent Field Safety Notice for Carestation 620 / 650 / 650c by Datex-Ohmeda, Inc.
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 43269/24
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12.12.2024
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Urgent Field Safety Notice for ELITe InGenius Consumable Set by ElitechGroup S.p.A.
Product group In-vitro diagnostics -
microbiological products
Reference 42131/24
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12.12.2024
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Urgent Field Safety Notice for PIEZOWAVE2 by Richard Wolf GmbH
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 42665/24
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12.12.2024
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Urgent Field Safety Notice for Synergy RF Console by Arthrex Inc.
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 41699/24
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12.12.2024
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Guidance for the application procedure
Guidance for the application procedure
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12.12.2024
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Renouncements
Online procedure to declare a renouncement in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG
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12.12.2024
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Non-submission renewals
Online procedure to declare the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG
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11.12.2024
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Urgent Field Safety Notice for redmount Space by hestomed GmbH
Product group General equipment for medical treatment -
ward equipment and equipment for emergency medical services
Reference 41643/24
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10.12.2024
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Urgent Field Safety Notice for Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e by Maquet Critical Care AB
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 13178/24
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10.12.2024
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Urgent Field Safety Notice for Revolution Maxima, Revolution Maxima Select by GE Hang Wei Medical Systems Co. Ltd
Product group Radiological technology -
CT scanners
Reference 41056/24
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10.12.2024
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Urgent Field Safety Notice for OMEGA Left Atrial Appendage (LAA) Occluder Device by Eclipse Medical Co. Ltd
Product group Non-active implants -
cardiac surgery
Reference 41600/24
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10.12.2024
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Urgent Field Safety Notice for UNID ROD by Medicrea International
Product group Non-active implants -
bone surgery
Reference 42328/24
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09.12.2024
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Direct Healthcare Professional Communication (DHPC) on metamizole-containing medicines: important measures to minimise the serious outcomes of known risk of agranulocytosis
Active substance: metamizole
The marketing authorisation holders of metamizole-containing medicinal products provide information on the early symptoms of agranulocytosis.
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09.12.2024
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Urgent Field Safety Notice for CADD-Solis Li-ion Rechargeable Battery Packs by Smiths Medical ASD, Inc. (Plymouth) is no. part of ICU Medical
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 32884/24
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09.12.2024
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Urgent Field Safety Notice for Neck Segment, with suture holes, standard, uncemen by Waldemar Link GmbH & Co. KG
Product group Non-active implants -
bone surgery
Reference 41608/24
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09.12.2024
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Direct Healthcare Professional Communication (DHPC) on Cyanokit 5 g powder for solution for infusion: Potential microbial contamination of certain batches
Active substance: Hydroxycobalamin
The company SERB SA informs about a potential microbial contamination and a possible resulting risk of infection.
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