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HSA Approval

SUGAMMADEX-TEVA SOLUTION FOR INJECTION 100MG/ML

Approval Number

SIN16962P

Drug Name

SUGAMMADEX-TEVA SOLUTION FOR INJECTION 100MG/ML

Product Name

SUGAMMADEX-TEVA SOLUTION FOR INJECTION 100MG/ML

Approval Date

February 26, 2024

Registrant

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Regulatory Information

Registrant

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

V03AB35

ATC Item Name

sugammadex

Manufacturer Information

Pharmaceutical Manufacturer

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Manufacturers

PLIVA Croatia Ltd.

Active Ingredients

Ingredient Name

Sugammadex Sodium eqv. to Sugammadex

Strength

100mg/ml

Drug MonographSugammadex

Documents

Package Inserts

Sugammadex Teva Solution for Injection PI.pdf

Approved: February 26, 2024

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SUGAMMADEX-TEVA SOLUTION FOR INJECTION 100MG/ML - HSA Approval | MedPath