PHPMaker 2020
Correction/Addition Request
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Product Information
Registration Number
BR-1122
Generic Name
Rituximab
Brand Name
Mabthera
Dosage Strength
1400 mg/11.7 mL
Dosage Form
Solution for Injection (SC)
Classification
Prescription Drug (RX)
Packaging
Type I USP/Ph.Eur. colourless glass vial sealed with butyl rubber stopper laminated with fluororesin film and crimped with an aluminum overseal fitted with a plastic flip-off disk x 15 mL (Box of 1's)
Pharmacologic Category
Antineoplastic Agents
Manufacturer
F. Hoffman-La Roche AG.
Country of Origin
Switzerland
Trader
N/A
Importer
Distributor
Application Type
Initial (Variation)
Issuance Date
26 February 2025
Expiry Date
26 February 2030
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