|
24.04.2025
|
Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 15442/25
|
|
24.04.2025
|
Direct Healthcare Professional Communication on Opzelura 15 mg/g cream: Important information regarding presence of particles in Opzelura cream
Active substance: Ruxolitinib phosphate
The company Incyte Biosciences Distribution B.V. informs about possible particles in Opzelura 15 mg/g cream, which may form during production from the active substance.
|
|
23.04.2025
|
Urgent Field Safety Notice for OTNI 17 Luci Connector by OTN Innovations B.V
Product group Orthopaedic / Rehabilitation technology -
prostheses (exoprostheses)
Reference 14725/25
|
|
23.04.2025
|
Urgent Field Safety Notice for VasoView Hemopro 2 by Maquet Cardiovascular
Product group Optics / Precision engineering -
endoscopes
Reference 14539/25
|
|
23.04.2025
|
Urgent Field Safety Notice for GOT Multi (SF6, C2F6, C3F8) by AL.CHI.MI.A. S.R.L.
Product group ophthalmological technology -
liquid media for ophthalmological purposes
Reference 14313/25
|
|
23.04.2025
|
Urgent Field Safety Notice for Eye wick by GRI Medical & Electronic Technology Co., Ltd.
Product group Dressings / Pads -
swabs, sponges, wipes, swabsticks
Reference 15470/25
|
|
23.04.2025
|
Urgent Field Safety Notice for Soltive Laser System by Gyrus ACMI, Inc.
Product group Optics / Precision engineering -
laser technology
Reference 13407/25
|
|
22.04.2025
|
Processing statistics
Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.
|
|
22.04.2025
|
Current processing statistics of the BfArM
State: March 2025
|
|
22.04.2025
|
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.
|
|
22.04.2025
|
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
|
|
22.04.2025
|
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.
|
|
17.04.2025
|
Urgent Field Safety Notice for Tornado Embolization MicrocoilT by Cook Incorporated
Product group Non-active implants -
special implants
Reference 15052/25
|
|
17.04.2025
|
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
|
|
17.04.2025
|
Urgent Field Safety Notice for Mecta-C Stand Alone screws by Medacta International SA
Product group Non-active implants -
bone surgery
Reference 15287/25
|
|
17.04.2025
|
Iris user survey
The Iris user survey is now available!
|
|
16.04.2025
|
Urgent Field Safety Notice for Codman Certas Programmable Valve System by Integra LifeSciences Mansfield
Product group Non-active implants -
special implants
Reference 02820/13
|
|
16.04.2025
|
Presentation Iris Webinar April 2025
Presentation Iris Webinar April 2025
|
|
16.04.2025
|
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
|
|
16.04.2025
|
Iris user questionnaire April 2025
Iris user questionnaire April 2025
|
