WAINZUA Solution for injection Ref.[114921] Active ingredients: Eplontersen

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

Wainzua 45 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless to yellow solution (pH of approximately 7.4 and osmolality 250 to 330 mOsm/kg).

Qualitative and quantitative composition

Each pre-filled pen contains 45 mg eplontersen (as eplontersen sodium) in 0.8 ml of solution.

Each ml contains 56 mg eplontersen (as eplontersen sodium).

For the full list of excipients, see section 6.1.

Active Ingredient

Eplontersen is a N-acetylgalactosamine (GalNAc)-conjugated 2′-O-2-methoxyethyl-modified chimeric gapmer antisense oligonucleotide (ASO) with a mixed backbone of phosphorothioate and phosphate diester internucleotide linkages. The GalNAc conjugate enables targeted delivery of the ASO to hepatocytes. The selective binding of eplontersen to the transthyretin (TTR) messenger RNA (mRNA) within the hepatocytes causes the degradation of both mutant and wild type (normal) TTR mRNA. This prevents the synthesis of TTR protein in the liver, resulting in significant reductions in the levels of mutated and wild type TTR protein secreted by the liver into the circulation.
List of Excipients

Sodium dihydrogen phosphate dihydrate
Disodium hydrogen phosphate anhydrous
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

0.8 ml sterile solution for injection in a single-use, type I glass syringe with a staked 27-gauge ½ inch (12.7 mm) stainless steel needle, rigid needle shield, and siliconised chlorobutyl elastomer stopper in a pre-filled pen.

Pack size of one single-use pre-filled pen.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/24/1875/001

Drugs

Drug Countries
WAINZUA France, Lithuania, Romania
 
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