Composition

Each 1 mL of solution for injection contains: Gadobutrol 604.72 mg (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium). 1 prefilled syringe with 7.5 ml contains 4535.4 mg gadobutrol 1 cartridge with 15 ml contains 9070.8 mg gadobutrol Excipient with known effect: 1 mL contains 0.00056 mmol (equivalent to 0.013 mg) of sodium  

ATC Code/ATCvet Code

V08CA09  

Product Category

Medical devices

Marketing Category

Prescription-only Medicine (POM)  

Packsize

7.5 mL x 1's (in prefilled syringe); 15 mL x 1's (in cartridge)  

Product Description

Solution for injection in prefilled syringe/cartridge. Clear, colourless to pale yellow liquid

Manufacturer Name

Bayer Pharma AG

Manufacturer Country

GERMANY  

Approval Date

2024-05-02  

Expiry Date

2029-04-29