Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Kynamro
Active substance: mipomersen
Indication: Kynamro is indicated as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apo B, total cholesterol (TC), non-high density lipoprotein-cholesterol (non-HDL-C) and lipoprotein (a) [Lp(a)] in patients with homozygous familial hypercholesterolaemia (HoFH) and in patients with severe heterozygous familial hypercholesterolaemia (severe HeFH).
Marketing Authorisation Holder: Genzyme Europe B.V.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/05/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2429 (2013)3359 of 29/05/2013