Paracetamol (Acetaminophen) Suppositories

Form: Suppositories

Strength: 120 mg/5 mL, 160 mg/5 mL

Reference Brands: Tylenol(US)

Category: Analgesic

Paracetamol (Acetaminophen) suspension is approved in the EU and US for fever and mild to moderate pain relief, especially in pediatric patients. In the EU, brands like Calpol are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data, with generic versions available. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate efficient market access for paracetamol suspension, ensuring adherence to European and American standards for safe, effective fever and pain management in children and adults.