Post-Authorisation Safety Study (PASS) for Flupirtine – Effect of Risk Minimisation Measures in Germany

Study identification

• EU PAS number:
  EUPAS14528
• Study ID:
  23384
• Official title and acronym:
  Post-Authorisation Safety Study (PASS) for Flupirtine – Effect of Risk Minimisation Measures in Germany
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a retrospective cohort study with pre-post design (before and after implementation of risk minimisation measures) using a longitudinal patient level Electronic Medical Records (EMR) database and a longitudinal patient level prescription database for Germany.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned:28/10/2014

Actual:28/10/2014

Study start date

Planned:01/07/2016

Actual:01/07/2016

Data analysis start date

Actual:15/07/2016

Date of final study report

Planned:31/12/2016

Actual:12/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hormosan Pharma GmbH

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)