Leqvio (inclisiran)
- Region
- 🇪🇺 EU
- Active substance
- inclisiran
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Hypercholesterolemia; Dyslipidemias
- CHMP opinion
- Thu 15 Oct 2020
- EU approval
- Wed 09 Dec 2020
- Application
- EMEA/H/C/005333
- ATC
- C10AX
- Official record
- www.ema.europa.eu
Indication
Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.