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HSA Approval

ARTINIBSA 4% WITH EPINEPHRINE SOLUTION FOR INJECTION 1:100000

SIN15913P

ARTINIBSA 4% WITH EPINEPHRINE SOLUTION FOR INJECTION 1:100000

ARTINIBSA 4% WITH EPINEPHRINE SOLUTION FOR INJECTION 1:100000

March 18, 2020

FONDACO PTE LTD

FONDACO PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFONDACO PTE LTD
Licence HolderFONDACO PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

SUBMUCOSAL

Medical Information

N01BB58

articaine, combinations

Manufacturer Information

FONDACO PTE LTD

Laboratorios Inibsa, S.A.

Active Ingredients

Adrenaline Tartrate 0.018mg eqv Adrenaline

0.01mg

Epinephrine

Articaine Hydrochloride

40.00 mg

Articaine

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ARTINIBSA 4% WITH EPINEPHRINE SOLUTION FOR INJECTION 1:100000 - HSA Approval | MedPath