What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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12/05/2025
Referenced at:
09/05/2025
FAQ Import of medicinal products 1. New Web Portal for the Submission of Applications or Notifications in Accordance with the Austrian Medicinal Products Import Act 2. Who is in charge of procedures r
Magnesium sulfate / sodium sulfate / potassium sulfate New
PSUR-outcome
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08/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Blood & Tissue
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08/05/2025
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International - Aarhus ApS that the donor KRISS is a carrier of haemochromatosis type 1.
The donor/gametes have been permanently blocked.
08/05/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank Cryos International - Aarhus ApS, darüber informiert wurde, dass der Spender KRISS Träger von Hämochromatose Typ 1 ist.
Der Spender/die Spendergameten wurden permanent gesperrt.
Referenced at:
Thiocolchicoside, paracetamol / thiocolchicoside New
PSUR-outcome
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07/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxytetracycline hydrochloride, hydrocortisone acetate, polymyxin B sulfate (ear/eye drops/suspension/ointment) New
PRAC signal recommendation
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06/05/2025
Risk for hearing and vestibular disorders. Further information and amendments to the product information can be found on the EMA website.
02/05/2025
Anlage zu § 1 Abs. 1 der Geschäftsordnung des Bundesamtes für Sicherheit im Gesundheitswesen gültig ab dem 30.04.2025.
Referenced at:
02/05/2025
Rules of Procedure (in German only) New Current rules of procedure and annex New Rules of procedure of the BASG (L_M71) | 99 KB Rules of Procedure of the Federal Office for Safety in Health Care valid