Study identification

PURI

https://redirect.ema.europa.eu/resource/49706

EU PAS number

EUPAS31001

Study ID

49706

Official title and acronym

Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
Spain
United Kingdom

Study description

This 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?”.

Study status

Finalised
Research institution and networks

Institutions

University of Copenhagen Denmark

Networks

Contact details

Olaf Klungel

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

Protocol Valproates V0.5 SEP2019_uploadversion

English (971.82 KB - PDF)View document
Updated protocol

AMEND Protocol Valproates V1.1 03DEC2021

English (1.27 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable