Observational pharmaco-epidemiological study on the use of Izalgi®

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27241
• EU PAS number:
  EUPAS9983
• Study ID:
  27241
• Official title and acronym:
  Observational pharmaco-epidemiological study on the use of Izalgi®
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Study objectives:Main objective: to describe the conditions of use of Izalgi® over a 6-month period in real treatment situations,Secondary objectives: To estimate and describe, in real 6-month treatment situations:• The characteristics of patients treated with Izalgi®,• The misuse of the product on the following points:- Indication of Izalgi®,- Contraindications of Izalgi®,- Posology,- Duration of treatment,• A drug abuse or dependence,• The efficacy of the product,• Overall tolerance,• Adverse Drug Reactions.
• Study status:
  Ongoing

Research institutions and networks

Institutions

CEMKA

Pharmaco-epidemiology department, CEMKA

France

Study timelines

Date when funding contract was signed

Actual: 28/03/2013

Study start date

Planned: 15/10/2015

Actual: 03/06/2016

Data analysis start date

Planned: 01/04/2017

Actual: 01/06/2018

Date of final study report

Planned: 30/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Mylan Medical SAS

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable