🇪🇺 Niacin plus laropiprant in European Union

EMA authorised Niacin plus laropiprant on 3 July 2008

Marketing authorisation

EMA — authorised 3 July 2008

  • Application: EMEA/H/C/000889
  • Marketing authorisation holder: Merck Sharp Dohme Ltd.
  • Local brand name: Tredaptive
  • Indication: Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (LDL) cholesterol and triglycerides and low high-density-lipoprotein (HDL) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol-lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It c
  • Status: withdrawn

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Other Cardiovascular approved in European Union

Frequently asked questions

Is Niacin plus laropiprant approved in European Union?

Yes. EMA authorised it on 3 July 2008.

Who is the marketing authorisation holder for Niacin plus laropiprant in European Union?

Merck Sharp Dohme Ltd. holds the EU marketing authorisation.