Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
Amvuttra 25 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless-to-yellow solution (pH of approximately 7; osmolality 210 to 390 mOsm/kg). |
Each pre-filled syringe contains vutrisiran sodium equivalent to 25 mg vutrisiran in 0.5 mL solution.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Vutrisiran is a chemically stabilized double-stranded small interfering ribonucleic acid (siRNA) that specifically targets variant and/or wild-type transthyretin (TTR) messenger RNA (mRNA). Vutrisiran causes the catalytic degradation of TTR mRNA in the liver, resulting in the reduction of serum levels of variant and wild-type amyloidogenic TTR protein thus reducing the deposition of TTR amyloid in tissues. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate dihydrate |
Pre-filled syringe (Type I glass) with stainless steel 29-gauge needle with a needle shield.
Amvuttra is available in packs containing one single-use pre-filled syringe.
Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
EU/1/22/1681/001
Date of first authorisation: 15 September 2022
| Drug | Countries | |
|---|---|---|
| AMVUTTRA | Croatia, Japan, Lithuania, Romania, United Kingdom, United States |
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