Drug utilisation study (DUS) on flupirtine-containing products Retrospective drug utilisation study using patient-level databases to characterise prescribing practices of flupirtine-containing drugs during routine clinical use and assess the main reasons for prescription by representative groups of prescribers

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23426
• EU PAS number:
  EUPAS11391
• Study ID:
  23426
• Official title and acronym:
  Drug utilisation study (DUS) on flupirtine-containing products Retrospective drug utilisation study using patient-level databases to characterise prescribing practices of flupirtine-containing drugs during routine clinical use and assess the main reasons for prescription by representative groups of prescribers
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Cohort study with pre-post design using a longitudinal patient level Electronic Medical Records (EMR) database and a longitudinal patient level prescription database for Germany. The DUS will be carried out in Germany because more than 90% of total prescriptions for flupirtine-containing medicinal products of MAHs in European Union Member States were issued in Germany.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 30/09/2015

Actual: 30/09/2015

Study start date

Planned: 01/10/2016

Actual: 01/10/2016

Date of final study report

Planned: 31/12/2016

Actual: 11/11/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

TEVA

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)