This is an observational, exposure-registration and follow-up study, to be conducted in the
United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant
subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the
risk of major birth defects.
The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development
and will be managed by INC Research. The Registry will be monitored by an independent
Advisory Committee of external experts in relevant specialties of teratology, epidemiology,
maternal and fetal medicine, and infectious disease medicine (external member details
available upon request).