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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