Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products
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
- EUPAS31095
- Specific Contract 02 implementing Framework service contract EMA/2018/28/PE
Full title
Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends
Principal investigator
Prof. Dr. Miriam Sturkenboom, University Medical Center Utrecht
Participating organisations
- Utrecht University, The Netherlands - consortium lead
- UMC Utrecht, The Netherlands - coordinator
- University of Copenhagen, Denmark
- University of Messina, Italy
- ARS Toscana, Italy
- PHARMO Institute, The Netherlands
- AEMPS, Spain
- FICF, Spain
Status
Completed (2022)
Deliverables
Peer-reviewed scientific publications
Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis. Durán CE, Riera-Arnau J, Abtahi S, Pajouheshnia R, Hoxhaj V, Gamba M, Alsina E, Martin-Perez M, Garcia-Poza P, Llorente-Garcia A, Gonzalez-Bermejo D, Ibánez L, Sabaté M, Vidal X, Ballarín E, Sanfélix-Gimeno G, Rodríguez-Bernal C, Peiró S, García-Sempere A, Sanchez-Saez F, Ientile V, Ingrasciotta Y, Guarneri C, Tanaglia M, Tari M, Herings R, Houben E, Swart-Polinder K, Holthuis E, Huerta C, Gini R, Roberto G, Bartolini C, Paoletti O, Limoncella G, Girardi A, Hyeraci G, Andersen M, Kristiansen SB, Hallgreen CE, Klungel O, Sturkenboom M. Front Pharmacol. 2023 Aug 17;14:1207976. doi: 10.3389/fphar.2023.1207976. PMID: 37663263; PMCID: PMC10469888.