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Product Information BR-1366-PI_01.pdf
Registration Number BR-1366
Generic Name Durvalumab
Brand Name Imfinzi
Dosage Strength 500 mg/10 mL (50 mg/mL)
Dosage Form Cocentrate for Solution for IV Infusion
Classification Prescription Drug (RX)
Packaging 10 mL Type I glass vial with chlorobutyl rubber stopper and a white flip-off aluminum seal (Box of 1's)
Pharmacologic Category -
Manufacturer Catalent Indiana, LLC
Country of Origin United States of America
Importer AstraZeneca Pharmaceuticals (Phils.), Inc.
Distributor AstraZeneca Pharmaceuticals (Phils.), Inc.
Application Type Monitored Release (MR)
Issuance Date 07 September 2021
Expiry Date 07 September 2024