424 results
Keyword Simvastatin Remove keyword
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Human medicine European public assessment report (EPAR): Cholib
fenofibrate, simvastatin, Dyslipidemias
Date of authorisation: 26/08/2013, Revision: 15, Authorised, Last updated: 20/04/2023substances , fenofibrate and simvastatin, and is used together with … the corresponding dose of simvastatin alone. How is Cholib used … known to alter the amount of simvastatin in the blood. How does Cholib … -
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Referral: Simvastatin Vale
simvastatin, associated names: Simvastatin Vale pharmaceuticals, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/03/2013, EC decision date: 27/05/2013, Last updated: 22/07/2013Simvastatin Vale … authorisation of the medicine Simvastatin Vale. The Agency's Committee … concluded that the benefits of Simvastatin Vale outweigh its risks … -
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Referral: Zocord
simvastatin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 22/01/2004, EC decision date: 28/04/2004, Last updated: 09/06/2004Commission final decision Overview Simvastatin is an inhibitor of the hydroxy-methyl-glutaryl … 3-hydroxy-3-methyl-glutaryl-Coenzyme A into mevalonic acid). Simvastatin is a serum lipid-lowering … the benefit/risk ratio of simvastatin is considered to be favourable … -
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Opinion/decision on a Paediatric investigation plan (PIP): simvastatin, fenofibrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Simvastatin / fenofibrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 18/05/2009, Last updated: 09/07/2009, Compliance check: XSimvastatin / fenofibrate Cardiovascular … Key facts simvastatin fenofibrate Cardiovascular … product specific waiver for simvastatin / fenofibrate (EMEA-000490-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Ezetimibe and simvastatin (fixed combination), Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 14/09/2008, Last updated: 10/10/2008, Compliance check: XEzetimibe and simvastatin (fixed combination) Endocrin … Ezetimibe and simvastatin (fixed combination … and Opinion Ezetimibe and simvastatin 000006-PIP0… European … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP03-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 23/07/2012, Last updated: 22/08/2012, Compliance check: XActive substance Ezetimibe simvastatin Therapeutic area Cardiovascular … specific waiver for ezetimibe / simvastatin (Inegy and associated names) (EMEA-000006-PIP03-12 … specific waiver for ezetimibe / simvastatin (Inegy and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/04/2011, Last updated: 12/05/2011, Compliance check: XActive substance Ezetimibe simvastatin Therapeutic area Cardiovascular … Ezetimibe simvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): sitagliptin phosphate monohydrate, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Sitagliptin phosphate monohydrate / simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/08/2009, Last updated: 22/10/2009, Compliance check: Xptin phosphate monohydrate / simvastatin Endocrinology-Gynaecology-Fe … ptin phosphate monohydrate / simvastatin … sitagliptin phosphate monohydrate simvastatin 000… European … -
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Opinion/decision on a Paediatric investigation plan (PIP): simvastatin, sitagliptin phosphate monohydrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Simvastatin / sitagliptin phosphate monohydrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/08/2009, Last updated: 22/10/2009, Compliance check: XSimvastatin / sitagliptin phosphate monoh … Simvastatin / sitagliptin phosphate monoh … sitagliptin phosphate monohydrate simvastatin 000… European … -
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Opinion/decision on a Paediatric investigation plan (PIP): sitagliptin phosphate monohydrate, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Sitagliptin phosphate monohydrate / simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/08/2009, Last updated: 22/10/2009, Compliance check: Xptin phosphate monohydrate / simvastatin Endocrinology-Gynaecology-Fe … ptin phosphate monohydrate / simvastatin … sitagliptin phosphate monohydrate simvastatin 000… European … -
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Opinion/decision on a Paediatric investigation plan (PIP): sitagliptin phosphate monohydrate, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Sitagliptin phosphate monohydrate / simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/09/2009, Last updated: 22/10/2009, Compliance check: Xptin phosphate monohydrate / simvastatin Endocrinology-Gynaecology-Fe … ptin phosphate monohydrate / simvastatin … sitagliptin phosphate monohydrate / simvastatin (EMEA-000538-PIP01-09) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): nicotinic acid, simvastatin, laropiprant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000253-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 20/08/2008, Last updated: 18/09/2008, Compliance check: Xsubstance nicotinic acid simvastatin laropiprant Therapeutic area … Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000253-PIP01-08 … Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000253-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): nicotinic acid, simvastatin, laropiprant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000064-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 20/08/2008, Last updated: 18/09/2008, Compliance check: Xsubstance nicotinic acid simvastatin laropiprant Therapeutic area … Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000064-PIP01-07 … Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000064-PIP01-07 … -
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Opinion/decision on a Paediatric investigation plan (PIP): nicotinic acid, simvastatin, laropiprant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000254-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 20/08/2008, Last updated: 18/09/2008, Compliance check: Xsubstance nicotinic acid simvastatin laropiprant Therapeutic area … Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000254-PIP01-08 … Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000254-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): simvastatin, Ramipril, acetyl salicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000631-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 27/11/2009, Last updated: 23/12/2009, Compliance check: XKey facts simvastatin Ramipril acetyl salicylic … product specific waiver for simvastatin / ramipril / acetyl salicylic … Word - Decision and Opinion simvastatin-ramipril-acetyl salicylic acid 000631-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: XDHA) in a ratio of 0.9-1.5), simvastatin Cardiovascular diseases … DHA) in a ratio of 0.9-1.5) simvastatin Cardiovascular diseasesP/120/2008Omega-3-acid … DHA) in a ratio of 0.9-1.5), simvastatin Capsule, soft Atherosclerotic … -
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Human medicine European public assessment report (EPAR): Nustendi
Bempedoic acid, Ezetimibe, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 27/03/2020,
, Revision: 5, Authorised, Last updated: 21/04/2022
combination with a statin called simvastatin it can increase the risk … the risk of side effects of simvastatin, therefore the dose of simvastatin must not be higher than 40 … sequestrant. Concomitant simvastatin therapy When Nustendi is … -
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Human medicine European public assessment report (EPAR): Nilemdo
Bempedoic acid, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 01/04/2020,, Revision: 6, Authorised, Last updated: 08/04/2022
combination with a statin called simvastatin it can increase the risk … the risk of side effects of simvastatin, therefore the dose of simvastatin must not be higher than 40 … once daily. Concomitant simvastatin therapy When Nilemdo is … -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023or difficulty sleeping); simvastatin, lovastatin (used to lower … -
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,
, Revision: 21, Authorised, Last updated: 02/03/2023
such as: • atorvastatin, simvastatin (medicines for lowering cholesterol … as: • atorvastatin, simvastatin (medicines for lowering cholesterol … -
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Human medicine European public assessment report (EPAR): Telzir
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 48, Authorised, Last updated: 23/08/2022paritaprevir (for hepatitis C), simvastatin or lovastatin (for lowering … -
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Human medicine European public assessment report (EPAR): Cholestagel
colesevelam (as hydrochloride), Hypercholesterolemia
Date of authorisation: 09/03/2004, Revision: 23, Authorised, Last updated: 25/05/2021with a statin (lovastatin, simvastatin or atorvastatin) in 491 patients … with a statin (lovastatin, simvastatin or atorvastatin) in 491 patients … -
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Human medicine European public assessment report (EPAR): Noxafil
posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Date of authorisation: 25/10/2005, Revision: 36, Authorised, Last updated: 22/03/2023used to treat malaria), simvastatin, lovastatin or atorvastatin … -
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Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, 
, Revision: 16, Authorised, Last updated: 08/05/2023
with over 40 mg per day of simvastatin (another medicine used to … with over 40 mg per day of simvastatin (another medicine used to … -
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Referral: Tredaptive, Pelzont and Trevaclyn
laropiprant, nicotinic acid, Article 20 procedures
Status: European Commission final decision, EC decision date: 22/03/2013, Last updated: 17/05/2013Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg … Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg …