Shanghai United Cell Biotechnology Co., Ltd.🇵🇭 Food and Drug Administration - Philippines
Approval Date
Jul 14, 2025
Approval ID
27641052c9c3c990
Company
Shanghai United Cell Biotechnology Co., Ltd.
Type
Standard
Approval Details
Approval Id
27641052c9c3c990
Drug Approval Philippines Name
OraVacs
Product Name
OraVacs
Registration Number
BR-664
Brand Name
OraVacs
Generic Name
Cholera Vaccine (inactivated, oral)
Dosage Form
Enteric-Coated Capsule
Dosage Strength
Formulation Each capsule contains: Inactivated Whole Cell (WC)-5.0 x 10^10 of Vibrio cholerae 01 Inaba, classical biotype (heat inactivated)
Recombinant cholera toxin B subunit (ICTB)--1 mg (produced in V. cholerae 01 Inaba, classical biotype or El Tor biotype)
