🇪🇺 LEQVIO in European Union

EMA authorised LEQVIO on 9 December 2020

Marketing authorisation

EMA — authorised 9 December 2020

  • Application: EMEA/H/C/005333
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Leqvio
  • 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.
  • Status: approved

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LEQVIO in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Cardiovascular approved in European Union

Frequently asked questions

Is LEQVIO approved in European Union?

Yes. EMA authorised it on 9 December 2020.

Who is the marketing authorisation holder for LEQVIO in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.