MedPath

None

Brand Name: None

Generic Name: Oral Poliomyelitis Vaccine (Types 1 and 3)[ Live, Attenuated]

Active
Registration Number

BR-1442

Dosage Form

Solution for Oral Administration

Issuance Date

February 7, 2024

Expiry Date

May 25, 2028

Product Information

Philippine FDA product specifications and classification details

Product Specifications

Dosage StrengthFormulation: Each dose of 2 drops (0.1 mL) contains live attenuated poliomyelitis virus (Sabin strain).: Type 1 ≥106.0CCID50 Type 3 ≥105.8CCID50
PackagingMultidose (20 doses). 2 mL in 4 mL Type I clear glass vial with grey bromobutyl rubber stopper and aluminum flip-off seal with Type 2 Vaccine Vial Monitor (VVM) + LDPE dropper (Box of 50's).

Classification

C
Classification
Prescription Drug (RX)
P
Pharmacologic
Vaccines
A
Application
Monitored Release (MR) [Reconstruction]
Philippine FDA Classification

Active Ingredients (1)

Complete list of active ingredients in this pharmaceutical product.

Oral Poliomyelitis Vaccine (Types 1 and 3)[ Live, Attenuated]Active
Monograph: oral poliomyelitis vaccine (types 1 and 3)[ live, attenuated]

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