05.04.2024
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Supply shortages
BfArM makes information on reported supply shortages available to the public.
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18.04.2024
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Terminologyserver
Terminologyserver
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08.03.2024
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Terms and conditions for the application Product Information Texts (PIT)
Terms and conditions for the application Product Information Texts (PIT) - Status: 05.05.2020
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08.03.2024
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Terms and conditions for the application Sunset Clause (SSC)
Terms and conditions for the application Sunset Clause (SSC) - Status: 05.05.2020
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08.03.2024
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Terms and conditions for the application Supply Shortages
Terms and conditions for the application Supply Shortages - Status: 05.03.2021
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18.01.2024
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Training manual on clinical assessment in action at ZaZiBoNa joint assessment session
Training manual on clinical assessment in action at ZaZiBoNa joint assessment session
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09.04.2024
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Trainings for PharmNet.Bund applications
In cooperation with the pharmaceutical industry associations BAH, BPI and vfa, the BfArM offers a training programme for the PharmNet.Bund applications.
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27.05.2024
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Update of Direct Healthcare Professional Communication (DHPC) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg: Possible risk of visible particles in the solution, use of a filter
Active substance: disodium folinate
The company medac GmbH informs that during the ongoing stability program visible particles have been found in the medicinal product Oncofolic 50 mg/ml solution for injection/infusion.
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10.06.2024
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Update of Iris version 5
We published a new version of the Iris software – V5.8.3-Y2024S1.
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11.07.2024
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Update of the Direct Healthcare Professional Communication (DHPC) on L-Arginine-Hydrochloride 21 % Braun (5 x 20 ml ampoules): Risk due to visible particles
Active substance: L-arginine hydrochloride
The company B. Braun Melsungen AG informs that visible particles have been found in the retained samples of several batches of the medicinal product L-Arginine Hydrochloride 21 % Braun.
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08.03.2024
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Urgent Field Safety Notice for 1.2 K+-Draht, Lanzette, 150mm by Medartis AG
Product group Non-active implants -
bone surgery
Reference 07571/24
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15.03.2024
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Urgent Field Safety Notice for 2.5 ADAPTIVE II TriLock DistRad.Pl Vol L by Medartis AG
Product group Non-active implants -
bone surgery
Reference 05262/24
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16.04.2024
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Urgent Field Safety Notice for 2.8 TriLock Screw 22mm, HD7, 1/Pkg by Medartis AG
Product group Non-active implants -
bone surgery
Reference 11851/24
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22.01.2024
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Urgent Field Safety Notice for 3 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM) by Zimmer Inc.
Product group Medical instruments for use in humans -
general instruments
Reference 01053/24
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17.01.2024
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Urgent Field Safety Notice for 3M Surgical / 3M Specialty Clipper Blades by 3M Health Care
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 01200/24
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12.03.2024
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Urgent Field Safety Notice for Abre Venous Self-expanding Stent System by Medtronic Inc
Product group Non-active implants -
special implants
Reference 07308/24
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22.04.2024
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Urgent Field Safety Notice for ABX Pentra Urea CP by HORIBA ABX SAS
Product group In-vitro diagnostics -
immunological products
Reference 11019/24
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15.03.2024
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Urgent Field Safety Notice for Access Substrate by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 06386/24
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06.02.2024
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Urgent Field Safety Notice for Accessory Sets, Syringe: Closed System Product Sampling by Origen Biomedical
Product group Injections / Infusions / Transfusions / Dialysis -
equipment for collecting blood products and peripheral stem cells
Reference 39378/23
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16.05.2024
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Urgent Field Safety Notice for Accu-Chek Guide by Roche Diabetes Care GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 14404/24
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