🇪🇺 LAROPIPRANT in European Union

EMA authorised LAROPIPRANT on 3 July 2008

Marketing authorisations

Application: EMEA/H/C/000897
Marketing authorisation holder: Merck Sharp Dohme Ltd
Local brand name: Trevaclyn
Indication: Trevaclyn 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). Trevaclyn 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 can
Status: withdrawn

Application: EMEA/H/C/000903
Marketing authorisation holder: Merck Sharp Dohme Ltd
Local brand name: Pelzont
Indication: Pelzont 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). Pelzont should be used in patients in combination with 3-hydroxy-3-methylglutaryl-coenzyme-A (HMG-CoA)-reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA-reductase inhibitor monotherapy is inadequate. It can be use
Status: withdrawn

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

Is LAROPIPRANT approved in European Union?

Yes. EMA authorised it on 3 July 2008; EMA authorised it on 3 July 2008.

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

Merck Sharp Dohme Ltd holds the EU marketing authorisation.