Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Leqvio 284 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear, colourless to pale yellow, and essentially free of particulates. |
Each pre-filled syringe contains inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution.
Each ml contains inclisiran sodium equivalent to 189 mg inclisiran.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Inclisiran |
Inclisiran is a cholesterol-lowering, double-stranded, small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. It is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet. |
| List of Excipients |
|---|
|
Water for injections |
1.5 ml solution in a pre-filled syringe (Type I glass) with plunger stopper (bromobutyl, fluorotec coated rubber) with needle and rigid needle shield.
Pack size of one pre-filled syringe.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/20/1494/001
| Drug | Countries | |
|---|---|---|
| LEQVIO | Austria, Estonia, Finland, France, Hong Kong, Croatia, Israel, Italy, Lithuania, Poland, Romania, United Kingdom |
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