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HSA Approval

DBL Irinotecan Injection Concentrate 20mg/ml

Approval Number

SIN13367P

Drug Name

DBL Irinotecan Injection Concentrate 20mg/ml

Product Name

DBL Irinotecan Injection Concentrate 20mg/ml

Approval Date

October 26, 2007

Registrant

PFIZER PRIVATE LIMITED

Licence Holder

PFIZER PRIVATE LIMITED

Regulatory Information

Registrant

PFIZER PRIVATE LIMITED

Licence Holder

PFIZER PRIVATE LIMITED

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION, CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

L01XX19

ATC Item Name

xl 01 xx 19

Manufacturer Information

Pharmaceutical Manufacturer

PFIZER PRIVATE LIMITED

Manufacturers

Zydus Hospira Oncology Private Limited

Active Ingredients

Ingredient Name

Irinotecan hydrochloride trihydrate

Strength

20mg/mL

Drug MonographIrinotecan

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