Post-Authorisation Safety Study (PASS) on Flupirtine-containing Medicinal Products - A retrospective, multicentre, non-interventional study to evaluate the effectiveness of the risk minimisation activities for flupirtine-containing medicinal products

Study identification

• EU PAS number:
  EUPAS11571
• Study ID:
  33294
• Official title and acronym:
  Post-Authorisation Safety Study (PASS) on Flupirtine-containing Medicinal Products - A retrospective, multicentre, non-interventional study to evaluate the effectiveness of the risk minimisation activities for flupirtine-containing medicinal products
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This study protocol was developed in the context of the European Medicines Agency (EMA) referral (article 107i of Directive 2001/83/EC EMEA/H/A-107i/1363) on the benefit and risks of the use of flupirtine. The study is required as part of the risk management plan (RMP) in order to assess the effectiveness of the risk minimisation measures as laid down in the revised Summary of Product Characteristics (SmPC) into therapy practice. The primary objective of this study is to evaluate the overall percentage of patients treated according to the revised SmPC.
• Study status:
  Finalised

Research institutions and networks

Institutions

SocraTec R&D GmbH

Multiple centres: 165 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:12/10/2015

Study start date

Actual:21/10/2015

Date of final study report

Planned:28/11/2016

Actual:23/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

TEVA 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)