Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex®/Epidyolex® During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107706
• EU PAS number:
  EUPAS107705
• Study ID:
  107706
• Official title and acronym:
  Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex®/Epidyolex® During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Bulgaria

  Croatia

  Cyprus

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Israel

  Italy

  Latvia

  Lithuania

  Luxembourg

  Malta

  Netherlands

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  Switzerland

  United Kingdom

  United States
• Study status:
  Planned

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual: 16/05/2023

Study start date

Planned: 30/11/2023

Date of final study report

Planned: 30/11/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GW Pharmaceuticals, part of Jazz pharmaceuticals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable