Assessing the safety of oseltamivir exposure in pregnant women

Study identification

• EU PAS number:
  EUPAS12875
• Study ID:
  21489
• Official title and acronym:
  Assessing the safety of oseltamivir exposure in pregnant women
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  This study will assess the association of exposure to oseltamivir during pregnancy and maternal outcomes, pregnancy outcomes and birth defects in the offspring.The research question will be addressed by conducting a cohort study (part 1), investigating all aspects of the research question.In a second part, a nested case-control study, the association between oseltamivir and malformations will further be investigated.
• Study status:
  Finalised

Research institutions and networks

Institutions

F. Hoffmann-La Roche

Study timelines

Date when funding contract was signed

Actual: 01/10/2014

Study start date

Planned: 01/06/2016

Actual: 01/03/2016

Date of final study report

Planned: 28/02/2017

Actual: 20/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

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

BV29684