CHMP variation assessment report
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چکیده
Scope of the variation: Update of Summary of Product Characteristics and Package Leaflet Update of the sections 4.3, 4.4, 4.5 and 5.1 of the SmPC based on a thorough QT/QTc study with ritonavir boosted saquinavir in healthy volunteers. Consequently, the PL was updated. Rapporteur: Milena Stain Product presentations affected: EU/1/96/026/001-2 Dossier modules/sections affected: Module 1, 2 and 5 Product Information affected: SmPC and Package Leaflet
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تاریخ انتشار 2010