What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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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
30/04/2025
Draft monographs for comments Only available on our German website
28/04/2025
PHAROS user group New The IT-System PHAROS was introduced at AGES MEA in July 2013. Since then many industry users have used the online electronic services. AGES MEA wants to extend the functionalitie
22/04/2025
Microsoft Word - L_I285_Guidance Notes _National Stockpiling Guidance notes for the notification of national stockpiling L_INS_VIE_EVEQ_I285_02 Valid from: 22.04.2025 1/22 Guidance notes for the notif
Referenced at: