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Pharmaceuticals - Union Register
List of nationally authorised medicinal products for human use
Simvastatin Vale and associated names
|Product name:||Simvastatin Vale and associated names|
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Treatment of homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy
|Marketing Authorisation Holder:||Not applicable|
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|28/05/2013||Referral||EMEA/H/A-29/1358||(2013)3232 of 27/05/2013|