YTTRIGA Radiopharmaceutical precursor, solution Ref.[11010] Active ingredients: Yttrium ⁹⁰Y chloride

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Eckert & Ziegler Radiopharma GmbH, Robert-Rössle-Str. 10, D-13125 Berlin, Germany

Product name and form

Yttriga radiopharmaceutical precursor, solution.

Pharmaceutical Form

Radiopharmaceutical precursor, solution.

Clear colourless solution, free of particulate matter.

Qualitative and quantitative composition

1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).

Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time. The volume is 0.02-3 ml.

Each 10ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time. The volume is 0.02-5 ml.

The theoretical specific activity is 20 GBq/microgram of Yttrium (90Y) (see section 6.5).

Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium ( 90Sr). It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium ( 90Zr).

Yttrium (90Y) has a half-life of 2.67 days (64.1 hours).

Active Ingredient Description
Yttrium ⁹⁰Y chloride

Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr). It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable zirconium (90Zr). 90Y-yttrium has a half-life of 2.67 days (64.1 hours).

List of Excipients

Hydrochloric acid (0.04 M)

Pack sizes and marketing

Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml with a flat bottom with a silicon stopper, closed with an aluminium seal.

Pack size: 1 vial.

Not all presentations may be marketed.

Marketing authorization holder

Eckert & Ziegler Radiopharma GmbH, Robert-Rössle-Str. 10, D-13125 Berlin, Germany

Marketing authorization dates and numbers

EU/1/05/322/001 (3 ml V-shaped vial)

EU/1/05/322/002 (10 ml flat bottom vial)

Date of first authorisation: 19/01/2006

Date of renewal: 06/01/2011

Drugs

Drug Countries
YTTRIGA Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania

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