Post-authorization Safety Study: Ponesimod Pregnancy Outcomes Program Utilizing Enhanced Pharmacovigilance Monitoring (POEM)

Study identification

• EU PAS number:
  EUPAS50031
• Study ID:
  50061
• Official title and acronym:
  Post-authorization Safety Study: Ponesimod Pregnancy Outcomes Program Utilizing Enhanced Pharmacovigilance Monitoring (POEM)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Canada

  Croatia

  Cyprus

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Italy

  Latvia

  Lithuania

  Luxembourg

  Malta

  Netherlands

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  United Kingdom

  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Laboratoires Juvisé Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned:02/03/2020

Study start date

Planned:01/06/2023

Actual:06/01/2023

Date of final study report

Planned:29/05/2032

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)