United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

mylan - simvastatin; fenofibrate - tablet - 20mg ; 145mg

Malta - English - Medicines Authority

adamed sp. z.o.o. pieńków 149, 05-152 czosnów, poland - rosuvastatin, ezetimibe - tablet - ezetimibe 10 mg rosuvastatin 5 mg - lipid modifying agents

Malta - English - Medicines Authority

adamed sp. z.o.o. pieńków 149, 05-152 czosnów, poland - rosuvastatin, ezetimibe - tablet - rosuvastatin 10 mg ezetimibe 10 mg - lipid modifying agents

Malta - English - Medicines Authority

adamed sp. z.o.o. pieńków 149, 05-152 czosnów, poland - rosuvastatin, ezetimibe - tablet - ezetimibe 10 mg rosuvastatin 20 mg - lipid modifying agents

Israel - English - Ministry of Health

organon pharma israel ltd., israel - atorvastatin as calcium trihydrate; ezetimibe - film coated tablets - atorvastatin as calcium trihydrate 10 mg; ezetimibe 10 mg - atorvastatin and ezetimibe - - prevention of cardiovascular eventsatozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs), either previously treated with a statin or not.- hypercholesterolaemiaatozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- homozygous familial hypercholesterolaemia (hofh)atozet is indicated as adjunctive therapy to diet for use in adults with hofh. patients may also receive adjunctive treatments (e.g., low-density lipoprotein [ldl] apheresis).

Israel - English - Ministry of Health

organon pharma israel ltd., israel - atorvastatin as calcium trihydrate; ezetimibe - film coated tablets - atorvastatin as calcium trihydrate 20 mg; ezetimibe 10 mg - atorvastatin and ezetimibe - - prevention of cardiovascular eventsatozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs), either previously treated with a statin or not.- hypercholesterolaemiaatozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- homozygous familial hypercholesterolaemia (hofh)atozet is indicated as adjunctive therapy to diet for use in adults with hofh. patients may also receive adjunctive treatments (e.g., low-density lipoprotein [ldl] apheresis).

Israel - English - Ministry of Health

organon pharma israel ltd., israel - atorvastatin as calcium trihydrate; ezetimibe - film coated tablets - atorvastatin as calcium trihydrate 40 mg; ezetimibe 10 mg - atorvastatin and ezetimibe - - prevention of cardiovascular eventsatozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs), either previously treated with a statin or not.- hypercholesterolaemiaatozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- homozygous familial hypercholesterolaemia (hofh)atozet is indicated as adjunctive therapy to diet for use in adults with hofh. patients may also receive adjunctive treatments (e.g., low-density lipoprotein [ldl] apheresis).

Israel - English - Ministry of Health

organon pharma israel ltd., israel - atorvastatin as calcium trihydrate; ezetimibe - film coated tablets - atorvastatin as calcium trihydrate 80 mg; ezetimibe 10 mg - atorvastatin and ezetimibe - - prevention of cardiovascular eventsatozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs), either previously treated with a statin or not.- hypercholesterolaemiaatozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- homozygous familial hypercholesterolaemia (hofh)atozet is indicated as adjunctive therapy to diet for use in adults with hofh. patients may also receive adjunctive treatments (e.g., low-density lipoprotein [ldl] apheresis).

Singapore - English - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - fenofibrate; simvastatin - tablet, film coated - fenofibrate 145.0mg; simvastatin 20.0mg

Malta - English - Medicines Authority

egis pharmaceuticals plc kereszturi ut 30-38 1106 budapest, hungary - rosuvastatin, ezetimibe - hard capsule - rosuvastatin 10 mg ezetimibe 10 mg - lipid modifying agents