Product Details
Rotarix oral suspension Tube (Strength Format)
Live attenuated human rotavirus RIX4414 strainnot 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