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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17818
• 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 institution and networks

Institutions

Evidera

United Kingdom

Evidera

United Kingdom

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

Study protocol

Initial protocol

D3820R00006 CSP - PRAC 01212015 final

Updated protocol

D3820R00006 CSP - PRAC 01212015 final_ppd OK

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)