REDEMPLO Solution for injection Ref.[116717] Active ingredients: Plozasiran

Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Arrowhead Pharmaceuticals Ireland Limited, One Spencer Dock, North Wall Quay, Dublin 1, D01 X9R7, Ireland

Product name and form

Redemplo 25 mg solution for injection in pre-filled syring.

Pharmaceutical Form
Solution for injection (injection). Clear, colourless to yellow solution with a pH of approximately 4.7–5.6 and osmolality of 320–380 mOsm/kg.

Qualitative and quantitative composition

Each single-dose pre-filled syringe contains plozasiran sodium equivalent to 25 mg plozasiran in 0.5 mL solution.

Each mL solution contains 50 mg plozasiran.

For the full list of excipients, see section 6.1.

Active Ingredient
Plozasiran
Plozasiran is a small interfering RNA (siRNA, double-stranded oligonucleotide) conjugated with N-acetylgalactosamine to facilitate delivery to and uptake by hepatocytes. In hepatocytes, plozasiran selectively degrades the mRNA for apolipoprotein C3 (APOC3) through the RNA interference mechanism resulting in reduced levels of hepatic and serum APOC3 protein. This, in turn, enhances the activity of lipoprotein lipase and hepatocyte uptake of TG-rich lipoprotein remnants leading to decreases in serum TG.

List of Excipients
Sodium chloride Water for injections

Pack sizes and marketing

Single-dose, type I glass pre-filled syringe with a bromobutyl stopper and needle with shield. Each pre-filled syringe contains 0.5 mL solution for injection.

Pack size of 1 pre-filled syringe.

Marketing authorization holder

Arrowhead Pharmaceuticals Ireland Limited, One Spencer Dock, North Wall Quay, Dublin 1, D01 X9R7, Ireland

Marketing authorization dates and numbers

EU/1/26/2041/001

Drugs

Drug	Countries
REDEMPLO	Lithuania, United States

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