Product Details

Rotarix oral suspension Tube (Strength Format)

Live attenuated human rotavirus RIX4414 strain
not less than 106.0 CCID50/1.5ml
Suspension

ROA

Oral

Applicant Name

Glaxo Smithkline Consumer Nigeria PLC

NRN

A6-0458

Status

Active


Composition

 

ATC Code/ATCvet Code

J07BH01  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1.5ML,50*1VIAL,1.5ML,1*1TUBE  

Product Description

Rotarix oral suspension Tube ROTAVIRUS RIX4414 STRAIN Live attenuated human rotavirus RIX4414 strain (not less than 106.0 CCID50); Sucrose, di-sodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sterile water. A6-0458 Vaccines & Biologicals Human Vaccines Imported Products 1.5ML,50*1VIAL,1.5ML,1*1TUBE 18/10/2022 GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD., INDUSTRIAL AVENUE ILUPEJU LAGOS 12711000 regulatorypharma-ng@gsk.com GlaxoSmithKline Biologicals S.A.,, 89, Rue de l'Institut, 1330 Rixensart, Belgium, Belgium

Manufacturer Name

Glaxosmithkline Biologicals S.A

Manufacturer Country

BELGIUM  

Approval Date

2024-01-31  

Expiry Date

2029-01-30