Drug Utilization Study to Characterize the Prescribing Practice of Flupirtine-containing Medicinal Products during Typical Clinical Use and to Assess the Main Reason for Prescription (Flupirtine-3304)

Study identification

• EU PAS number:
  EUPAS12177
• Study ID:
  23066
• Official title and acronym:
  Drug Utilization Study to Characterize the Prescribing Practice of Flupirtine-containing Medicinal Products during Typical Clinical Use and to Assess the Main Reason for Prescription (Flupirtine-3304)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This study will employ a retrospective cohort analysis of the IMS® Disease Analyzer database in four annual time intervals from calendar years 2012 until 2015, for Germany and all flupirtine-containing products to analyse the prescribing practice of flupirtine-containing medicinal products during typical clinical use.
• Study status:
  Finalised

Research institutions and networks

Institutions

MEDA Pharma

Study timelines

Date when funding contract was signed

Planned:17/10/2014

Actual:17/10/2014

Study start date

Planned:01/01/2012

Actual:01/01/2012

Date of interim report, if expected

Planned:30/06/2015

Actual:23/06/2015

Date of final study report

Planned:30/06/2016

Actual:17/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MEDA Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)