Rotavirus Vaccine

Form: Oral liquid vaccine (suspension), Powder for reconstitution

Strength: 2 mL RotaTeq; 1 mL Rotarix

Reference Brands: RotaTeq, Rotarix(US)

Category: Vaccines

Rotavirus vaccines are approved in both the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing excellence in compliance with GMP and IVDR standards. In the US, FDA approval requires rigorous clinical evaluation and safety data, while in the EU, CE marking certifies conformity with in vitro diagnostic regulations. These vaccines undergo validation, stability testing, and extensive quality 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 safe, effective prevention of rotavirus infections, vital for reducing childhood diarrhea and supporting global health initiatives.