PROHANCE Solution for injection Ref.[7670] Active ingredients: Gadoteridol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Bracco International B.V., Strawinskylaan 3051, 1077 ZX, Amsterdam, The Netherlands

Product name and form

ProHance 279.3 mg/ml, solution for injection.

Pharmaceutical Form

Sterile solution for intravenous injection.

Qualitative and quantitative composition

Gadoteridol 279.3mg/ml (0.5M).

Active Ingredient Description
Gadoteridol

Gadoteridol is a non-ionic paramagnetic contrast medium for Magnetic Resonance Imaging. Gadoteridol is for diagnostic use only.

List of Excipients

Calteridol calcium
Tromethamine
Hydrochloric acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

Vials: Type 1 glass vials with grey butyl stoppers and aluminium seals containing 5,10, 15 or 20ml.

Marketing authorization holder

Bracco International B.V., Strawinskylaan 3051, 1077 ZX, Amsterdam, The Netherlands

Marketing authorization dates and numbers

PL14447/0001

29 October 1992 / 24 April 2001

Drugs

Drug Countries
PROHANCE Austria, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Poland, Romania, United Kingdom

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