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
  • 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 木瓜福利影视 

Participating organisations

  • Utrecht 木瓜福利影视, The Netherlands - consortium lead, coordinator
  • UMC Utrecht, The Netherlands
  • 木瓜福利影视 of Copenhagen, Denmark 
  • ARS, Italy 
  • PHARMO Institute, The Netherlands 
  • AEMPS, Spain 
  • FICF, Spain 
  • LSHTM, UK 

Status

Completed (2022)

Deliverables

Peer-reviewed scientific publications

. Abtahi S, Pajouheshnia R, Dur谩n 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, Ib谩nez L, Limoncella G, Mart铆n-P茅rez 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.