What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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10/01/2025
0125_Register bewilligter AM Betriebe Österreich_Rohdaten.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenznummer Betriebsstandort Straße PLZ Ort Umfang der Bewilligung gemäß § 63 AMG 481867
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10/01/2025
0125_Bearbeitungsstand.xlsx BASG / AGES Institut Überwachung Abteilung GMDP und BTVI Verfahrens- nummer Lizenz- nummer Bewilligungsinhaber Betriebsstandort Straße PLZ Ort Clock stop Auftrag Zuteilung
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10/01/2025
0125_Register Arzneimittelvermittler.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenznummer Betriebsstandort Straße PLZ Ort 484516 AGILIS Trading GmbH Kärntner Str. 26/3 1010 Wien 484493 Am
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CHMP Monthly News
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09/01/2025
Up-to-date information from the 09.12.-12.12.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
09/01/2025
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
09/01/2025
Annual Reports and Facts Folder New For resource reasons, replacing past practice of bilingual annual reports, BASG started in 2021 to publish an annual „Facts Folder“ in english only, aiming particul
09/01/2025
1 FACTS FEDERAL OFFICE FOR SAFETY IN HEALTH CARE 2 3 BASG/AGES MEA Federal Office for Safety in Health Care (BASG) and Austrian Medicines and Medical Devices Agency (AGES MEA) The Federal Office for S
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Risperidone oral solution New
PRAC signal recommendation
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09/01/2025
Risk for medication errors associated with accidental overdoses in children and adolescents treated with risperidone 1 mg/mL oral solution. Further information and amendments to the product information can be found on the EMA website.
Nitric oxide New
PRAC signal recommendation
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09/01/2025
Risk for pulmonary oedema in patients with veno-occlusive disease. Further information and amendments to the product information can be found on the EMA website.
09/01/2025
GUIDANCE NOTES for the notification of medicine shortages GUIDELINE for the notification of medicine shortages L_INS_VIE_EVEQ_I242_02 Valid from: 08.01.2025 1/21 GUIDANCE NOTES for the notification of
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