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Product Information BR-1138_PI_02.pdf
Registration Number BR-1138
Generic Name Pembrolizumab
Brand Name Keytruda
Dosage Strength 100 mg/4 mL (25 mg/mL)
Dosage Form Solution for Injection (IV Infusion)
Classification Prescription Drug (RX)
Packaging 10 mL Type I glass vial, with a grey chlorobutyl stopper and an aluminum seal with a dark blue flip-off cap (Box of 1's) 10 mL Type I glass vial with a grey chlorobutyl stopper and an aluminum seal with a dark blue flip-off cap (Box of 1's) [For Government Tender (DOH-Pack-Cancer Assistance Fund)]
Pharmacologic Category Monoclonal Antibodies
Manufacturer MSD International GmbH T/A MSD Ireland (Carlow)
Country of Origin Ireland
Trader
Importer Merck Sharp & Dohme (I.A.) LLC
Distributor N/A
Application Type Initial (Variation)
Issuance Date 31 March 2025
Expiry Date 31 March 2030