Nebenwirkungen · Leqvio
Leqvio 284 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 5
HOS-146424 · Präparat HOS-099518
Paediatric population The safety and efficacy of inclisiran were assessed in two phase III studies in paediatric patients. The first study was a 24-month, two-part study of 141 patients aged 12 to less than 18 years with HeFH, consisting of a 12-month double-blind, placebo-controlled part followed by a 12-month open-label part. The second study was a 24-month, two-part study of 13 patients aged 12 to less than 18 years with homozygous familial hypercholesterolaemia (HoFH), consisting of a 12-month double-blind, placebo-controlled part followed by a 12-month open-label part. The safety profile of inclisiran reported in these studies was consistent with the safety profile reported in adult patients and no new safety findings were observed during the studies.
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Version 2026-10-02T12:00:00Z · SHA-256 8ca71d1fd7bc5e2a47da2e9fbf75972c9eacf2c37333f4bb35c0e09c5b7316ef · Passage 5898b98401745b8213790848ebb336f8d6b54210d9eb32ab794b5cefd15634bc · Zeichen 1922–2688 im Abschnitt