A5002283491- Pregnancy and Medication Impact
- Eosinophilic Esophagitis
- Reproductive System and Pregnancy
- Pregnancy and preeclampsia studies
- Microscopic Colitis
- Inflammatory Bowel Disease
- Pharmacovigilance and Adverse Drug Reactions
- Computational Drug Discovery Methods
- Biosimilars and Bioanalytical Methods
Abstract Data on the use of golimumab (GLM) during pregnancy are limited. This study evaluated outcomes in women treated with GLM pregnancy. Cumulative data GLM‐exposed pregnancies from Company's global safety database (GSD) summarized. Cases were medically confirmed maternal exposures to or within 3 months prior conception a reported outcome. Pregnancy (e.g., live births) and congenital anomalies prospectively cases (i.e., outcome not known when first company) presented descriptive manner....
In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of dossier for initial marketing authorization medicinal product or with an application involving significant change to existing authorization. A comprehensive revision EU Guideline on Good Pharmacovigilance Practices (GVP) Module V-Risk Systems (Revision [Rev] 2), adopted in March 2017, provides framework developing more focused, actionable, and risk-proportionate RMPs. This paper describes Janssen experience...
ABSTRACT Purpose To present the main findings of a post‐authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in real‐world setting. Methods This observational population‐based cohort included data from pregnancies ending 2006–2018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases ulcerative colitis diagnoses were identified. Based on prescription fills 90 days prior until delivery, infants assigned one four...