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HSA Approval

PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL

SIN17236P

PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL

PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL

May 15, 2025

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGOLDPLUS UNIVERSAL 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

A02BC02

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Mefar Ilac Sanayii A.S.

Active Ingredients

Pantoprazole sodium sesquihydrate eqv Pantoprazole

40.0mg/vial

Pantoprazole

Documents

Package Inserts

Pantoprazole Kalceks Powder for Solution for Infusion PI.pdf

Approved: May 15, 2025

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PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL - HSA Approval | MedPath