Irinotecan

Form: Liposomal injection (intravenous infusion)

Strength: 43 mg/ml

Reference Brands: Onivyde

Category: Liposomal Drug Delivery

Liposomal irinotecan (Onivyde) is regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in accordance with GMP and MDR standards. In the US, FDA approval involved extensive clinical validation and safety assessments. In the EU, CE marking certifies conformity with MDR regulations. These formulations undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to high-quality liposomal irinotecan, supporting effective cancer treatment and improved patient outcomes worldwide.