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Product Information DR-XY38878_PI_01.pdf
Registration Number DR-XY38878
Generic Name Gadobutrol
Brand Name Gadovist
Dosage Strength 1 mmol/mL (equivalent to 604.72 mg/mL)
Dosage Form Solution For Intravenous Injection
Classification Prescription Drug (RX)
Packaging 5 mL Type I colorless glass pre-filled syringe
Pharmacologic Category Paramagnetic Contrast Media
Manufacturer Bayer AG
Country of Origin Germany
Trader
Importer Bayer Philippines, Inc.
Distributor
Application Type Renewal
Issuance Date 22 March 2023
Expiry Date 08 May 2028