Nebenwirkungen · Vijoice
Vijoice 50 mg granules in sachet · Abschnitt 4.8 · PDF-Seite 39
HOS-153421 · Präparat HOS-100978
P2. * Forty patients in EPIK-P3 continued to be treated with alpelisib in a prospective period. Additional safety data from the 3-year analysis of the EPIK-P3 prospective period, with an additional median duration of exposure of 39.1 months (range: 17- 42 months) did not show additional ADRs or clinically relevant laboratory abnormalities. # Adverse drug reactions reported outside of the EPIK-P1/EPIK-P2/EPIK-P3 safety population considered. The frequency category is estimated from the EPIK-P2 study as per the SmPC Guideline 2009 section 4.8, Adverse reactions from spontaneous reporting.
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Version 2026-08-26T16:40:18Z · SHA-256 c8dab2ee4d59e608a790c3eaa5b28218615335c6617e4800a0f6b088049e780e · Passage 460e50e224cfcd8660d300f5bda709e2b63efd07959397db1fa53dc68d03e387 · Zeichen 7986–8601 im Abschnitt