An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations

Study identification

• EU PAS number:
  EUPAS12598
• Study ID:
  17818
• Official title and acronym:
  An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Norway

  Sweden

  United Kingdom
• Study description:
  This is a drug utilization study that uses observational data from multiple countries. The study utilizes a retrospective new users cohort (patients newly prescribed naloxegol) study design in each of the countries.
• Study status:
  Finalised

Research institutions and networks

Institutions

PPD Evidera

Sweden

United Kingdom

United States

PPD Evidera

Sweden

United Kingdom

United States

IQVIA

United Kingdom

IMS Health

Study timelines

Date when funding contract was signed

Actual:13/10/2015

Study start date

Actual:01/12/2015

Date of final study report

Actual:15/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Kyowa Kirin

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)