Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantNOVARTIS (SINGAPORE) PTE LTD
Licence HolderSANDOZ SINGAPORE PTE. LTD.
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
TABLET, FILM COATED
ORAL
Medical Information
R03DC03
montelukast
Manufacturer Information
SANDOZ SINGAPORE PTE. LTD.
Genveon Ilac Sanayi ve Ticaret A.S
Lek S.A (Strykow)
Lek S.A. (Warszawa) (Primary and secondary packager)