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22.04.2025
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Marketable medicinal products in the responsibility of the BfArM
On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are updated on a monthly basis.
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22.04.2025
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Urgent Field Safety Notice for Xpert BCR/ABL Ultra, Xpert BCR/ABL Ultra p190 by Cepheid
Product group In-vitro diagnostics -
immunological products
Reference 15288/25
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22.04.2025
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Direct Healthcare Professional Communication (DHPC) on Livopan (Nitrous Oxide/Oxygen) 50 %/50 % gas for medical use, compressed: Risk of gas leakage and interruption of gas supply to patients when the flow rate is above 8 l/min
Active substance: Nitrous Oxide, Oxygen
The company Linde Sverige AB informs about a quality defect of the medicinal product Livopan when used with a Fir Tree connector for direct connection with O2/N2O breathing systems.
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17.04.2025
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Urgent Field Safety Notice for Tornado Embolization MicrocoilT by Cook Incorporated
Product group Non-active implants -
special implants
Reference 15052/25
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17.04.2025
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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 15159/25
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17.04.2025
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Urgent Field Safety Notice for Mecta-C Stand Alone screws by Medacta International SA
Product group Non-active implants -
bone surgery
Reference 15287/25
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17.04.2025
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Iris user survey
The Iris user survey is now available!
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16.04.2025
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Urgent Field Safety Notice for Codman Certas Programmable Valve System by Integra LifeSciences Mansfield
Product group Non-active implants -
special implants
Reference 02820/13
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16.04.2025
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Presentation Iris Webinar April 2025
Presentation Iris Webinar April 2025
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16.04.2025
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Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc
Product group Medical electronics / Electromedical devices -
electric blood glucose meters
Reference 00725/25
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16.04.2025
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Iris user questionnaire April 2025
Iris user questionnaire April 2025
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16.04.2025
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Publication of the Joint Announcement by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines (PEI) on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013
The Joint Announcement of BfArM and PEI replaces the second Announcement on the notification of variations for purely national licences in accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 which are within the BfArM's responsibility in accordance with Section 77 dated 15 June 2016 and considers the amendments to the Variation Regulation (Regulation (EC) No. 1234/2008) following the entry into force of Commission Delegated Regulation (EU) 2024/1701.
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16.04.2025
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Medical Research Act
Publication of the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Marketing Authorisation
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16.04.2025
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Request for supergrouping
Request for supergrouping
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16.04.2025
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Variations
Publication of the Joint Announcement by BfArM and PEI on the Notification of Variations for Purely National Marketing Authorisations in Accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 dated 16 April 2025
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15.04.2025
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Information Iris user group meeting - May 2025
Information Iris user group meeting - May 2025
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15.04.2025
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Urgent Field Safety Notice for AirLife Infant Heated Wire Circuits by Vyaire Medical Mettawa
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 14591/25
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15.04.2025
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Urgent Field Safety Notice for HMRS and KRH by Stryker Orthopaedics-Mahwah
Product group Non-active implants -
bone surgery
Reference 14552/25
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15.04.2025
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Urgent Field Safety Notice for CODMAN Disposable Perforator (Codman Einmalbohrer) by Integra LifeSciences Corp.
Product group Medical instruments for use in humans -
bone surgery
Reference 14566/25
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14.04.2025
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Urgent Field Safety Notice for Brilliance CT Big Bore; Philips CT Big Bore by Philips Medical Systems Nederland B.V.
Product group Radiological technology -
CT scanners
Reference 13305/25
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