Levocetirizine/cetirizine levels in human milk – an observational, clinical study among breastfeeding women

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46214
• EU PAS number:
  EUPAS46213
• Study ID:
  46214
• Official title and acronym:
  Levocetirizine/cetirizine levels in human milk – an observational, clinical study among breastfeeding women
• DARWIN EU® study:
  No
• Study countries:
  Norway
• Study description:
  This is a open-label observational study conducted to determine (levo)cetirizine levels in breast milk of breastfeeding women and monitor adverse events in nursing infants. In total, 25 to 40 lactating women in Norway will be recruited. The study is part of the IMI ConcePTION project, as a demonstration project in WP4 of ConcePTION.
• Study status:
  Ongoing

Research institution and networks

Institutions

Pharmacoepidemiology and Drug Safety Research Group (PharmaSafe), University of Oslo

Norway

Networks

ConcepTION

Study timelines

Date when funding contract was signed

Planned: 01/03/2019

Actual: 01/04/2019

Study start date

Planned: 28/04/2021

Actual: 01/07/2021

Date of final study report

Planned: 01/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

IMI 2- Grant agreement No 821520

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable