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14 p, 1.9 MB 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, Shahab (Utrecht University) ; Pajouheshnia, Romin (Utrecht University) ; Durán, Carlos E. (University Medical Center Utrecht) ; Riera-Arnau, Judit (Hospital Universitari Vall d'Hebron) ; Gamba, Magdalena (Utrecht University) ; Alsina, Ema (University Medical Center Utrecht) ; Hoxhaj, Vjola (University Medical Center Utrecht) ; Andersen, Morten (University of Copenhagen. Department of Drug Design and Pharmacology) ; Bartolini, Claudia (Agenzia Regionale di Sanità della Toscana) ; Kristiansen, Sarah Brøgger (University of Copenhagen. Department of Drug Design and Pharmacology) ; Brown, Jeremy (London School of Hygiene & Tropical Medicine) ; Hallgreen, Christine Erikstrup (University of Copenhagen. Copenhagen Centre for Regulatory Science) ; Garcia-Poza, Patricia (Agencia Espanola de Medicamentos y Productos Sanitarios) ; Gardarsdottir, Helga (UMCU. Department of Clinical Pharmacy) ; Gini, Rosa (Agenzia Regionale di Sanità della Toscana) ; Girardi, Anna (Agenzia Regionale di Sanità della Toscana) ; Holthuis, Emily (PHARMO Institute for Drug Outcomes Research) ; Huerta, Consuelo (Universidad Complutense de Madrid. Departamento de Salud Pública y Materno-Infantil) ; Ibáñez, Luisa (Hospital Universitari Vall d'Hebron) ; Limoncella, Giorgio (Agenzia Regionale di Sanità della Toscana) ; Martín-Pérez, Mar (Agencia Espanola de Medicamentos y Productos Sanitarios) ; Paoletti, Olga (Agenzia Regionale di Sanità della Toscana) ; Roberto, Giuseppe (Agenzia Regionale di Sanità della Toscana) ; Souverein, Patrick (Utrecht University) ; Swart, Karin M. A. (PHARMO Institute for Drug Outcomes Research) ; Wing, Kevin (London School of Hygiene & Tropical Medicine) ; Sturkenboom, Miriam (University Medical Center Utrecht) ; Klungel, Olaf (Utrecht University) ; Universitat Autònoma de Barcelona
Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018. To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions. [...]
2023 - 10.1007/s40264-023-01314-3
Drug Safety, june 2023, p. 1-14  
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