LOCAMETZ Kit for radiopharmaceutical preparation Ref.[50606] Active ingredients: Gallium ⁶⁸Ga gozetotide

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Locametz 25 micrograms kit for radiopharmaceutical preparation.

Pharmaceutical Form

Kit for radiopharmaceutical preparation.

One vial of white lyophilised powder (powder for solution for injection).

Qualitative and quantitative composition

The vial contains 25 micrograms of gozetotide.

The radionuclide is not part of the kit.

Excipient with known effect: The vial contains 28.97 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Gallium ⁶⁸Ga gozetotide
List of Excipients

Gentisic acid
Sodium acetate trihydrate
Sodium chloride

Pack sizes and marketing

Locametz is supplied as a multidose kit for the radiopharmaceutical preparation of gallium (68Ga) gozetotide solution for injection (see sections 2 and 3). Locametz contains one 10 mL type I Plus glass vial closed with a rubber stopper and sealed with a flip-off cap.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/22/1692/001

Drugs

Drug Countries
LOCAMETZ Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Romania, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.