Study identification

EU PAS number

EUPAS10541

Study ID

27036

Official title and acronym

The Mycophenolate Pregnancy Registry

DARWIN EU® study

No

Study countries

United States

Study description

The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points and at the estimated date of delivery. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Annette Stemhagen

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Genentech, Inc. Novartis Pharma. Corp. Accord Healthcare, Inc. Alkem Lab. Ltd. Alkem Lab.Ltd. U.S. REMS Agent Apotex Corp. Mylan Pharma., Inc. Pfizer, Inc. Roxane Lab., Inc. Sandoz Incorporated Teva Pharma. USA, Inc. Vintage Pharma., LLC
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)