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HSA Approval

ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 8,000 IU (80 MG)/ 0.8 ML

Approval Number

SIN17084P

Drug Name

ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 8,000 IU (80 MG)/ 0.8 ML

Product Name

ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 8,000 IU (80 MG)/ 0.8 ML

Approval Date

September 11, 2024

Registrant

SANDOZ SINGAPORE PTE. LTD.

Regulatory Information

Registrant

SANDOZ SINGAPORE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION

Route of Administration

SUBCUTANEOUS, INTRAVASCULAR, INTRAVENOUS BOLUS

Medical Information

ATC Code

B01AB05

Manufacturer Information

Pharmaceutical Manufacturer

SANDOZ SINGAPORE PTE. LTD.

Manufacturers

ROVI PHARMA INDUSTRIAL SERVICES, S.A. (Julián Camarillo)

Active Ingredients

Ingredient Name

Enoxaparin Sodium

Strength

8,000 IU (80 MG) /0.8 ML

Drug MonographEnoxaparin sodium

Documents

Package Inserts

Enoxaparin Sandoz PI September 2024.pdf

Approved: September 11, 2024

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ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 8,000 IU (80 MG)/ 0.8 ML - HSA Approval | MedPath