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A regulatory submission is not anticipated before late 2026, and a market launch is unlikely before 2027 or 2028

In a statement, the EMA said the PRAC reviewed evidence from the published literature, including observational studies, as well as data submitted by the marketing authorisation holders (MAHs), which included non-clinical, clinical, and post-marketing data

Quiarato Lozano et al., 2022) demonstrated that the fetal testes of sertraline-exposed rats exhibited a large number of eosinophils, a reduction in the nuclear volume of testicular interstitial cells, a decrease in the expression of proliferating cell nuclear antigen (PCNA) and Wilms tumor protein (WT1), and delayed puberty

Can Diabetes Medications Cause Bowel or Urinary Incontinence