Nebenwirkungen · Lojuxta
Lojuxta 2 mg hard capsules Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules · Abschnitt 4.8 · PDF-Seite 17
HOS-127399 · Präparat HOS-096397
The safety and effectiveness of lomitapide have been established in paediatric patients with HoFH aged 5 to 17 years. 43 patients have been treated with lomitapide in a Phase 3 study (see section 5.1). No new safety concerns were identified. Gastrointestinal events were less frequent and less severe in paediatric patients. No clinically significant changes in serum oestradiol or testosterone were reported and increases were within expected developmental ranges (see section 5.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-25T14:24:00Z · SHA-256 56c36935b5cda4380e359902f1acbc5ec5bb081beeb96ca75e5ad86521fcd98c · Passage 81ec6acd25e150d8284d1c4b850d3f3dfd926616880a01946ae67ab757d8a5d0 · Zeichen 10983–11466 im Abschnitt