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1.
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  
Registre complet - Creative Commons
2.
12 p, 1.6 MB Myocarditis and pericarditis associated with SARS-CoV-2 vaccines : A population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countries / Bots, Sophie H. (Utrecht University) ; Riera-Arnau, Judit (Hospital Universitari Vall d'Hebron) ; Belitser, Svetlana V. (Utrecht University) ; Messina, Davide (Agenzia Regionale di Sanitá) ; Aragón, María (Institut Universitari d'Investigació en Atenció Primària Jordi Gol) ; Alsina, Ema (Hospital Universitari Vall d'Hebron) ; Douglas, Ian J. (London School of Hygiene & Tropical Medicine) ; Durán, Carlos E. (Hospital Universitari Vall d'Hebron) ; García-Poza, Patricia (Agencia Española de Medicamentos y Productos Sanitarios) ; Gini, Rosa (Agenzia Regionale di Sanitá) ; Herings, Ron M. C. (PHARMO Institute for Drug Outcomes Research) ; Huerta, Consuelo (Agencia Española de Medicamentos y Productos Sanitarios) ; Sisay, Malede Mequanent (Hospital Universitari Vall d'Hebron) ; Martín-Pérez, Mar (Agencia Española de Medicamentos y Productos Sanitarios) ; Martin, Ivonne (Hospital Universitari Vall d'Hebron) ; Overbeek, Jetty A. (PHARMO Institute for Drug Outcomes Research) ; Paoletti, Olga (Agenzia Regionale di Sanitá) ; Pallejà-Millán, Meritxell (Institut Universitari d'Investigació en Atenció Primària Jordi Gol) ; Schultze, Anna (London School of Hygiene & Tropical Medicine) ; Souverein, Patrick (Utrecht University) ; Swart, Karin M. A. (PHARMO Institute for Drug Outcomes Research) ; Villalobos Martínez, Felipe (Institut Universitari d'Investigació en Atenció Primària Jordi Gol) ; Klungel, Olaf H. (Utrecht University) ; Sturkenboom, Miriam (Hospital Universitari Vall d'Hebron) ; Universitat Autònoma de Barcelona
Background: Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity of events, especially in age- and sex-stratified analyses. Methods: Population-based cohort study with nested self-controlled risk interval (SCRI) using healthcare data from five European databases. [...]
2022 - 10.3389/fphar.2022.1038043
Frontiers in Pharmacology, Vol. 13 (november 2022)  
Registre complet - Creative Commons

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