Actemra (Tocilizumab) & Exposure in Pregnancy

Details

Basic Details

Status

Complete

Last Updated

Tuesday, August 7, 2018

Health Outcome(s)

exposure in pregnancy

Purpose

Drug Use

Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR

No

Regulatory Determination / Use

This study provided information to evaluate reported difficulties in enrollment in ongoing pregnancy registry.

Result(s) (1)

Actemra (Tocilizumab) Utilization Among Pregnant Women

Regulatory Link(s) (1)

Approval Letter with PMR/PMC Commitments