Impact of EU label changes for systemic diclofenac products: post-referral prescribing trends

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33662
• EU PAS number:
  EUPAS24089
• Study ID:
  33662
• Official title and acronym:
  Impact of EU label changes for systemic diclofenac products: post-referral prescribing trends
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Netherlands

  United Kingdom
• Study description:
  To evaluate the impact of the risk minimisation measures implemented in 2013 to manage the cardiovascular risks of systemic diclofenac containing medicinal products authorised in the European Union (EU) in clinical practice
• Study status:
  Finalised

Research institution and networks

Institutions

MEMO Research, University of Dundee

United Kingdom (Northern Ireland)

UCL School of Pharmacy, University College London

United Kingdom

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 06/09/2017

Actual: 06/09/2017

Study start date

Planned: 01/07/2018

Actual: 01/07/2018

Date of final study report

Planned: 06/01/2019

Actual: 06/01/2019

Sources of funding

EMA

Study protocol

Initial protocol

final Study Protocol Diclofenac_130318 (002)

Regulatory

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