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HSA Approval

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML

Approval Number

SIN16967P

Drug Name

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML

Product Name

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML

Approval Date

March 5, 2024

Registrant

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

Registrant

GOLDPLUS UNIVERSAL PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION

Route of Administration

INTRAVENOUS, INTRAMUSCULAR, RECTAL

Medical Information

ATC Code

N05CD08

ATC Item Name

midazolam

Manufacturer Information

Pharmaceutical Manufacturer

GOLDPLUS UNIVERSAL PTE LTD

Manufacturers

HBM Pharma s.r.o.

Active Ingredients

Ingredient Name

Midazolam Hydrochloride eqv. to Midazolam

Strength

1.0mg/mL

Drug MonographMidazolam

Documents

Package Inserts

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION INFUSION PI.pdf

Approved: March 5, 2024

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