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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38866
• EU PAS number:
  EUPAS26363
• Study ID:
  38866
• Official title and acronym:
  Impact of EU label changes for hydroxyzine 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 2015 to manage the potential risk of QT interval prolongation and cardiac arrhythmia of hydroxyzine 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)

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

UCL School of Pharmacy, University College London

United Kingdom

NHS National Services Scotland Glasgow, UK, University of Southern Denmark Denmark, University of Strathclyde Glasgow

Contact details

Thomas MacDonald

Study contact

[e-mail]

Thomas MacDonald

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 22/03/2018

Actual: 22/03/2018

Data collection

Planned: 01/07/2019

Actual: 01/07/2019

Date of final study report

Planned: 23/08/2019

Actual: 22/09/2019

Sources of funding

EMA

Study protocol

Initial protocol

Study Protocol Hydroxyzine_20072018 clean

Regulatory

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