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HSA Approval

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML

SIN16967P

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML

March 5, 2024

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, SOLUTION

INTRAVENOUS, INTRAMUSCULAR, RECTAL

Medical Information

N05CD08

midazolam

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

HBM Pharma s.r.o.

Active Ingredients

Midazolam Hydrochloride eqv. to Midazolam

1.0mg/mL

Midazolam

Documents

Package Inserts

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION INFUSION PI.pdf

Approved: March 5, 2024

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