TRYVIO

批准信原文要点

This Prior Approval sNDA provides for changes to Section 12.3 of the approved Tryvio prescribing information to convey conclusions from completed Study ID-080-111 ... effect of multiple-dose aprocitentan on the single-dose pharmacokinetics of combined oral contraceptives.

批准信原文要点

This Prior Approval sNDA provides for changes to the approved Tryvio label to remove text regarding the Tryvio REMS and proposed modifications to the approved Tryvio risk evaluation and mitigation strategy (REMS).

批准信原文要点

This Changes Being Effected sNDA provides for proposed modifications to the approved Tryvio risk evaluation and mitigation strategy (REMS).

批准信原文要点

This Changes Being Effected supplemental new drug application provides for proposed modifications to the approved Tryvio risk evaluation and mitigation strategy (REMS).