- Pharmacovigilance and Adverse Drug Reactions
- Drug-Induced Adverse Reactions
- Inflammatory mediators and NSAID effects
- Pharmaceutical studies and practices
Samjin Pharm (South Korea)
2024
Following the withdrawal of propacetamol in Europe owing to safety issues, regulatory authority South Korea requested a post-marketing surveillance study investigate its profile.
Abstract Upon withdrawal of propacetamol, an injectable formulation the paracetamol prodrug, in Europe due to safety concerns, South Korea’s regulatory body requested a post-marketing surveillance study exploring its profile. We characterized regional disparities adverse events (AE) associated with propacetamol between Asia and using World Health Organization’s pharmacovigilance database, VigiBase. performed disproportionality analyses reporting odds ratios (rOR) information component (IC)...