Product Details

Cervarix Vaccine

Human papillomavirus bivalent (types 16 & 18) L1 protein vaccine, recombinant
20 mcg/0.5 mL; 20 mcg/0.5 mL
Suspension for injection

ROA

Intramuscular

Applicant Name

GlaxoSmithKline Consumer Nigeria PLC (GSK)

NRN

A6-0012

Status

Active


Composition

Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted), Suspension for injection. Each dose (0.5 mL) contains: Human Papillomavirus type 16 L1 protein^1 20 micrograms, Human Papillomavirus type 18 L1 protein^1 20 micrograms, 3-O-desacyl-4’- monophosphoryl lipid A (MPL)^2 50 micrograms, Aluminium hydroxide, hydrated^2 0.5 milligrams Al^3+ 1. L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system 2. The GlaxoSmithKline proprietary AS04 adjuvant system is composed of aluminium hydroxide and 3-O-desacyl-4’- monophosphoryl lipid A (MPL)  

ATC Code/ATCvet Code

J07BM02  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 x 0.5 mL (in pre-filled syringe/vial)  

Product Description

Suspension for Injection

Manufacturer Name

Glaxosmithkline Biologicals S.A

Manufacturer Country

BELGIUM  

Approval Date

2023-11-30  

Expiry Date

2028-11-29