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HSA Approval

SALACLAV POWDER FOR SOLUTION FOR INJECTION 1.2G/VIAL

SIN15043P

SALACLAV POWDER FOR SOLUTION FOR INJECTION 1.2G/VIAL

SALACLAV POWDER FOR SOLUTION FOR INJECTION 1.2G/VIAL

July 4, 2016

PAN-MALAYAN PHARMACEUTICALS PTE LTD

PAN-MALAYAN PHARMACEUTICALS PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPAN-MALAYAN PHARMACEUTICALS PTE LTD
Licence HolderPAN-MALAYAN PHARMACEUTICALS PTE LTD

Product Classification

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

Formulation Information

INJECTION, POWDER, FOR SOLUTION

INTRAVENOUS

Medical Information

J01CR02

amoxicillin and beta-lactamase inhibitor

Manufacturer Information

PAN-MALAYAN PHARMACEUTICALS PTE LTD

Sandoz Industrial Products, S.A. (intermediate 5:1 Blend)

Laboratorio Reig Jofre S.A.

Active Ingredients

Potassium Clavulanate 238.4 mg Eqv Clavulanic acid

200 mg

Clavulanic acid

Amoxicillin Sodium 1060.3mg eqv Amoxicillin

1000 mg

Amoxicillin

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