Status: Finalised First registered on: 21/05/2018
Last updated on: 16/02/2020
1. Study identification
EU PAS Register NumberEUPAS24089
Official titleImpact of EU label changes for systemic diclofenac products: post-referral prescribing trends
Study title acronym
Study typeObservational study
Brief description of the studyTo 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
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsMEMO
Department/Research groupMedicines Monitoring Unit
Organisation/affiliationUniversity of Dundee
Details of (Primary) lead investigator
Title Professor
Last name MacDonald
First name Thomas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

NHS National Services Scotland, Glasgow, UK
PHARMO Institute for Drug Outcomes Research, Netherlands
University College, London
University of Southern Denmark, Denmark
University of Strathclyde, Glasgow
Countries in which this study is being conducted
International study

Denmark
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/09/201706/09/2017
Start date of data collection01/07/201801/07/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report06/01/201906/01/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeEuropean Medicines Agency100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name MacDonald
First name Thomas
Address line 1Medicines Monitoring Unit/Hypertension Research Centre
Address line 2Ninewells Hospital & Medical School 
Address line 3Mailbox 2, Level 7 
CityDundee 
PostcodeDD1 9 SY 
CountryUnited Kingdom
Phone number (incl. country code)441382383119 
Alternative phone number441382383232 
Fax number (incl. country code)441382643204 
Public Enquiries
Title Professor 
Last name MacDonald 
First name Thomas 
Address line 1Medicines Monitoring Unit/Hypertension Research Centre 
Address line 2Ninewells Hospital & Medical School 
Address line 3Mailbox 2, Level 7 
CityDundee 
PostcodeDD1 9 SY 
CountryUnited Kingdom 
Phone number (incl. country code)441382383119 
Alternative phone number441382383232 
Fax number (incl. country code)441382643204 
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