Status: Planned First registered on: 07/01/2020
Last updated on: 01/08/2020
1. Study identification
EU PAS Register NumberEUPAS31001
Official titleImpact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends
Study title acronym
Study typeObservational study
Brief description of the studyThis study will address the research question, “What was the effect of the EU label changes and the revised pregnancy prevention programme (2018) on utilization of valproate containing medicinal products and to what extent did prescribers and patients comply with recommendations?”.
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 belongsUtrecht University Pharmacoepidemiology Center
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Website/Homepagewww.uu.nl/pecp
Details of (Primary) lead investigator
Title Professor
Last name Klungel
First name Olaf
Is this study being carried out with the collaboration of a research network?
Yes
EU PE&PV research network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

ARS
University of Copenhagen, Denmark
Countries in which this study is being conducted
International study

Denmark
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed25/02/201925/02/2019
Start date of data collection01/10/2020
Start date of data analysis01/11/2020
Date of interim report, if expected
Date of final study report25/12/2021
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 scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Klungel
First name Olaf
Address line 1Universiteitsweg 99
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands
Phone number (incl. country code)31-6-28831313 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address o.h.klungel@uu.nl
Public Enquiries
Title Professor 
Last name Klungel 
First name Olaf 
Address line 1Universiteitsweg 99 
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands 
Phone number (incl. country code)31-6-28831313 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address o.h.klungel@uu.nl 
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