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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date07 Mar 1977 |
The Mycophenolate Pregnancy Registry
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified.
This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.
100 Clinical Results associated with Avet Lifesciences Ltd.
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100 Translational Medicine associated with Avet Lifesciences Ltd.