Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
Onpattro 2 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). White to off-white, opalescent, homogeneous solution (pH approximately 7). |
Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles.
Excipients with known effect: Each mL of concentrate contains 3.99 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Patisiran |
Patisiran is a double-stranded small interfering ribonucleic acid (siRNA) that specifically targets a genetically conserved sequence in the 3’ untranslated region of all mutant and wild-type TTR mRNA. Through a natural process called RNA interference (RNAi), patisiran causes the catalytic degradation of TTR mRNA in the liver, resulting in a reduction of serum TTR protein, a carrier of retinol binding protein which facilitates transport of vitamin A in the blood. |
| List of Excipients |
|---|
|
DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino)butanoate) |
5 mL concentrate in a Type I glass vial with a chlorobutyl stopper and an aluminium flip-off cap. Pack size of 1 vial.
Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
EU/1/18/1320/001
Date of first authorisation: 27 August 2018
| Drug | Countries | |
|---|---|---|
| ONPATTRO | Austria, Brazil, Canada, Cyprus, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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