The Mycophenolate Pregnancy Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27036
• 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 institution and networks

Institutions

Campbell Alliance

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual: 06/02/2009

Study start date

Actual: 20/11/2012

Date of final study report

Planned: 31/12/2021

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

Study protocol

Initial protocol

MPR-ML22679_Protocol_version_6

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)

Other study registration identification numbers and links

ML22679