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HSA Approval

EVICEL Fibrin Sealant (Human) Solution, 50-90 mg/ml, 800-1200 IU/ml

Approval Number

SIN13921P

Drug Name

EVICEL Fibrin Sealant (Human) Solution, 50-90 mg/ml, 800-1200 IU/ml

Product Name

EVICEL Fibrin Sealant (Human) Solution, 50-90 mg/ml, 800-1200 IU/ml

Approval Date

February 23, 2011

Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

SOLUTION

Route of Administration

OTHERS

Medical Information

ATC Code

B02BC

ATC Item Name

局部止血药

Manufacturer Information

Pharmaceutical Manufacturer

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

Manufacturers

OMRIX biopharmaceuticals Ltd

Active Ingredients

Ingredient Name

Human Thrombin

Strength

800-1200 IU/ml

Drug MonographHuman thrombin

Ingredient Name

Clottable Protein (Human Fibrinogen)

Strength

50-90 mg/ml

Drug MonographPlasma protein fraction (human)

Documents

Package Inserts

Evicel PI.pdf

Approved: August 5, 2022

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