🇪🇺 AEGR-733 in European Union

EMA authorised AEGR-733 on 31 July 2013

Marketing authorisation

EMA — authorised 31 July 2013

  • Application: EMEA/H/C/002578
  • Marketing authorisation holder: Chiesi Farmaceutici SpA
  • Local brand name: Lojuxta
  • Indication: Lojuxta is indicated as an adjunct to a low?fat diet and other lipid?lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.
  • Pathway: exceptional circumstances
  • Status: approved

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Frequently asked questions

Is AEGR-733 approved in European Union?

Yes. EMA authorised it on 31 July 2013.

Who is the marketing authorisation holder for AEGR-733 in European Union?

Chiesi Farmaceutici SpA holds the EU marketing authorisation.