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The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to Gilenya before (up to 8 weeks before last menstrual period) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.
Major malformations, minor congenital anomalies & overall pregnancy outcomes will be collected; Complications during pregnancy, potential AEs on the physical & immune system development of the offspring, & any other adverse pregnancy/maternal outcomes. [ Time Frame: Throughout the entirety of a patient's participation in the study which would include 9 months of pregnancy and 1 year of follow up post pregnancy ]
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Women with MS who become pregnant and were exposed to at least one dose of Gilenya during pregnancy (or up to 8 weeks before last menstrual period).
Pregnancy and reported confirmed or suspected maternal exposure to Gilenya any time during pregnancy or shortly before pregnancy (up to 8 weeks before LMP).
There are no specific exclusion criteria for this registry.
Other protocol-defined inclusion/exclusion criteria may apply