Pregnancy Registry for Eurartesim

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30212
• EU PAS number:
  EUPAS6929
• Study ID:
  30212
• Official title and acronym:
  Pregnancy Registry for Eurartesim
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  A 5 year European multi-centre pregnancy registry for patients exposed to Eurartesim whilst pregnant which aims to assess the live birth incidence of minor and major congenital birth defects following exposure to Eurartesim whilst pregnant. Both mother and child will be followed from enrolment until 12 months after the end of the pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

ICON Commercialisation & Outcomes

Germany

Ireland

Multiple centres: 31 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/11/2011

Actual: 01/11/2011

Study start date

Planned: 01/06/2012

Actual: 03/08/2015

Date of final study report

Planned: 01/01/2019

Actual: 17/04/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sigma-Tau

Study protocol

Initial protocol

3351_Sigma Tau_Pregnancy Registry_Protocol_20120626_v12.0_Clean_signed

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)