What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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22/05/2025
How to contact us New Federal Office for Safety in Health Care (BASG - Bundesamt für Sicherheit im Gesundheitswesen) Austrian Medicines and Medical Devices Agency (AGES MEA - AGES Medizinmarktaufsicht
Naphazoline New
Additional template
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15/05/2025
Further information can be found in the CMDh minutes from march 2025.
Naphazoline, naphazoline/zinc sulphate New
PSUR-outcome
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15/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
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.
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.
Acenocoumarol New
PSUR-outcome
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22/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
21/04/2025
Clinical trials of medicinal products Overview BASG fee schedule for clinical studies Withdrawal for technical reasons Information and training material BASG fee schedule for clinical studies As of 01
Busulfan New
PSUR-outcome
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15/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tiagabine New
PSUR-outcome
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07/04/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.