Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate
For more information on this project, please contact the EU PE&PV research network at eupepv@uu.nl.
Project information
- EU PE&PV research network
- EUPAS31001
- Specific Contract 01 implementing Framework service contract EMA/2018/28/PE
Full title
Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends
Principal investigator
Prof. Dr. Olaf Klungel, Utrecht University
Participating organisations
- Utrecht University, The Netherlands - consortium lead, coordinator
- UMC Utrecht, The Netherlands
- University of Copenhagen, Denmark
- ARS, Italy
- PHARMO Institute, The Netherlands
- AEMPS, Spain
- FICF, Spain
- LSHTM, UK
Status
Completed (2022)
Deliverables
Peer-reviewed scientific publications
Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study. Abtahi S, Pajouheshnia R, Durán CE, Riera-Arnau J, Gamba M, Alsina E, Hoxhaj V, Andersen M, Bartolini C, Kristiansen SB, Brown J, Hallgreen CE, Garcia-Poza P, Gardarsdottir H, Gini R, Girardi A, Holthuis E, Huerta C, Ibánez L, Limoncella G, Martín-Pérez M, Paoletti O, Roberto G, Souverein P, Swart KMA, Wing K, Sturkenboom M, Klungel O. Drug Saf. 2023 Jul;46(7):689-702. doi: 10.1007/s40264-023-01314-3. Epub 2023 Jun 9. PMID: 37294532; PMCID: PMC10252161.