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Product Information
Registration Number DR-XY26429
Generic Name Gadoteric Acid
Brand Name Dotarem
Dosage Strength 0.5mmol/mL (Equi. To 279.32mg/mL)
Dosage Form Solution for Injection (IV)
Classification Prescription Drug (RX)
Packaging 10mL and 20mL Type II Clear glas Vial with Type I chlorobutyl rubber stopper and aluminum cap
Pharmacologic Category Paramagnetic Contrast Media
Manufacturer Guerbet
Country of Origin France
Trader
Importer Fernando Medical Enterprises, Inc.
Distributor Fernando Medical Enterprises, Inc.
Application Type Automatic Renewal
Issuance Date 30 June 2023
Expiry Date 20 July 2028