Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantGLAXOSMITHKLINE PTE LTD
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
INTRAMUSCULAR
Medical Information
J07BX05
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GlaxoSmithKline Biologicals SA
GlaxoSmithKline Biologicals SA (adjuvant)
GlaxoSmithKline Vaccines S.r.l. (adjuvant)
Active Ingredients
RSVPreF3 antigen
120mcg/0.5mL
rsvpref 3 antigen