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HSA Approval

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

SIN13921P

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

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

February 23, 2011

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SOLUTION

OTHERS

Medical Information

B02BC

局部止血药

Manufacturer Information

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

OMRIX biopharmaceuticals Ltd

Active Ingredients

Human Thrombin

800-1200 IU/ml

Human thrombin

Clottable Protein (Human Fibrinogen)

50-90 mg/ml

Plasma protein fraction (human)

Documents

Package Inserts

Evicel PI.pdf

Approved: August 5, 2022

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