Polyethylene Glycol (PEG) Powder

Form: Powder for Solution

Strength: 17 g/packet for bowel prep; Miralax (24.3 g/erts) for laxative

Reference Brands: GoLYTELY, MoviPrep, Miralax

Category: Gastrointestinal Drugs

Polyethylene glycol (PEG) powder for solution, marketed as Moviprep, Colyte, and Fortral in the EU and US, is approved for bowel cleansing prior to colonoscopy. Regulatory approval requires detailed dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety protocols. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports swift approval, safe use, and global availability of PEG bowel preparation solutions to facilitate accurate diagnosis and improve gastrointestinal health worldwide.