Aktuelles Humanmedizin
Aktuelle Informationen aus dem Bereich Humanmedizin
Anforderungen für Einzelfallmeldungen in Österreich
071106_Reporting-Requirements-AT_DDL.pdf (321.91 KB)
Information über Electronic Reporting (E2B) für Zulassungsinhaber
070129_E2B.pdf (233.13 KB)
Electronic Reporting (E2B) für Zulassungsinhaber
061023-E2B.pdf (226.19 KB)
European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs
Final Questions and Answers on the review of non-selective NSAIDs
061024-Q_A_on_NSAIDs_Article_5_3__FINAL.pdf (40.16 KB)
EU Synchronisation of PSUR submission schemes
061003-PSUR_synchronisation_HMA_site.pdf (25.11 KB)
Question and Answers on PSUR Synchronisation
061003-Q_A_PSUR_HMA_website.pdf (17.4 KB)
HBD Liste 2006
Draft Questions and Answers on ketoprofen, ketorolac and piroxicam
060926-Piroxicam_QA.pdf (42.83 KB)
Draft Questions and Answers on the review of non-selective NSAIDs
060926_NSAIDs_QA.pdf (42.65 KB)
EU Synchronisierung der PSUR Vorlage
060711_PSUR_Harmonisierung_in_der_EU.pdf (34.06 KB)
