418 results
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS)
clopidogrel (as hydrochloride), Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Date of authorisation: 21/09/2009,
, Revision: 9, Withdrawn, Last updated: 24/10/2017
Pharma (previously Clopidogrel HCS) Myocardial Infarction Peripheral … Pharma (previously Clopidogrel HCS) … Previously known as Clopidogrel HCS. Me dic ina l p ro du ct … -
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Human medicine European public assessment report (EPAR): Clopidogrel HCS
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 8, Authorised, Last updated: 01/08/2018
Clopidogrel HCS Vascular Diseases Cardiovascular … Clopidogrel HCS … Clopidogrel HCS, INN-clopidogrel 30 … -
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 11, Authorised, Last updated: 17/08/2023
Amlodipine / Valsartan Mylan Cardiovascular Diseases Vascular … controlled on either amlodipine or valsartan taken alone. ‘Essential’ … substances , amlodipine and valsartan. It is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,
, Revision: 18, Authorised, Last updated: 13/09/2023
substances sacubitril and valsartan. This medicine is the same … Neparvis, sacubitril and valsartan, work in different ways. Sacubitril … occurs in heart failure. Valsartan is an ‘angiotensin-II-receptor … -
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Human medicine European public assessment report (EPAR): Entresto (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 18, Authorised, Last updated: 12/09/2023substances sacubitril and valsartan. How is Entresto used? Entresto … Entresto, sacubitril and valsartan, work in different ways. Sacubitril … occurs in heart failure. Valsartan is an ‘angiotensin-II-receptor … -
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Human medicine European public assessment report (EPAR): Dafiro
amlodipine, valsartan, Hypertension
Date of authorisation: 15/01/2007, Revision: 30, Authorised, Last updated: 11/11/2022amlodipine / valsartan … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … olmesartan, telmisartan and valsartan 3 Sipahi I, Debanne SM … -
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Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril, valsartan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000316-PIP02-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate solid oral dosage form
Decision date: 13/08/2021, Last updated: 30/06/2023, Compliance check: V, 20/05/2022Active substance sacubitril valsartan Therapeutic area Cardiovascular … investigation plan for sacubitril / valsartan (Entresto), (EMEA-000316-PIP02-11-M05 … investigation plan for sacubitril / valsartan (Entresto), (EMEA-000316-PIP02-11-M05 … -
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Human medicine European public assessment report (EPAR): Dafiro HCT (updated)
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 03/11/2009, Revision: 25, Authorised, Last updated: 27/09/2023substances , amlodipine, valsartan and hydrochlorothiazide … tablets containing amlodipine, valsartan and hydrochlorothiazide in … combination of amlodipine, valsartan and hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Copalia HCT (updated)
amlodipine, valsartan, hydrochlorothiazide, Hypertension
Date of authorisation: 03/11/2009, Revision: 24, Authorised, Last updated: 27/09/2023substances , amlodipine, valsartan and hydrochlorothiazide … tablets containing amlodipine, valsartan and hydrochlorothiazide in … combination of amlodipine, valsartan and hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Exforge HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 15/10/2009, Revision: 23, Authorised, Last updated: 21/12/2022amlodipine besilate / valsartan / hydrochlorothiazide … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … olmesartan, telmisartan and valsartan 3 Sipahi I, Debanne SM … -
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Human medicine European public assessment report (EPAR): Exforge
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 16/01/2007, Revision: 31, Authorised, Last updated: 11/11/2022amlodipine / valsartan … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … olmesartan, telmisartan and valsartan 3 Sipahi I, Debanne SM … -
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Human medicine European public assessment report (EPAR): Copalia
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 15/01/2007, Revision: 29, Authorised, Last updated: 11/11/2022amlodipine / valsartan … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … olmesartan, telmisartan and valsartan 3 Sipahi I, Debanne SM … -
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Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril, valsartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000316-PIP03-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet, Granules
Decision date: 14/08/2020, Last updated: 18/06/2021, Compliance check: XActive substance sacubitril valsartan Therapeutic area Cardiovascular … specific waiver for sacubitril / valsartan (Entresto and associated … specific waiver for sacubitril / valsartan (Entresto and associated … -
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Human medicine European public assessment report (EPAR): Imprida
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 17/01/2007, Revision: 20, Withdrawn, Last updated: 11/05/2017controlled on amlodipine or valsartan monotherapy. More information … for Imprida (amlodipine / valsartan) in the European Union (EU … substances, amlodipine and valsartan. There are other medicinal … -
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Human medicine European public assessment report (EPAR): Imprida HCT
amlodipine, valsartan, hydrochlorothiazide, Hypertension
Date of authorisation: 15/10/2009, Revision: 3, Withdrawn, Last updated: 22/10/2012combination of amlodipine, valsartan and hydrochlorothiazide (HCT … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … olmesartan, telmisartan and valsartan 3 Sipahi I, Debanne SM … -
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Opinion/decision on a Paediatric investigation plan (PIP): Exforge, valsartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001680-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Orodispersible tablet
Decision date: 05/12/2014, Last updated: 17/02/2015, Compliance check: XExforge Active substance valsartan Amlodipine besilate Therapeutic … waiver Amlodipine (besylate) / valsartan for treatment of hypertension … Amlodipine (besylate) / valsartan for treatment of hypertension … -
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Opinion/decision on a Paediatric investigation plan (PIP): Imprida HCT, valsartan, hydrochlorothiazide, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000399-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2009, Last updated: 06/03/2009, Compliance check: XKey facts Imprida HCT valsartan hydrochlorothiazide Amlodipine … for amlodipine besylate, valsartan, hydrochlorothiazide, (Imprida … for amlodipine besylate, valsartan, hydrochlorothiazide, (Imprida … -
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Opinion/decision on a Paediatric investigation plan (PIP): Copalia HCT, valsartan, hydrochlorothiazide, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000397-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2009, Last updated: 06/03/2009, Compliance check: XCopalia HCT Active substance valsartan hydrochlorothiazide Amlodipine … for amlodipine besylate, valsartan, hydrochlorothiazide, (Copalia … for amlodipine besylate, valsartan, hydrochlorothiazide, (Copalia … -
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Opinion/decision on a Paediatric investigation plan (PIP): Dafiro HCT, valsartan, hydrochlorothiazide, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000398-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2009, Last updated: 06/03/2009, Compliance check: XDafiro HCT Active substance valsartan hydrochlorothiazide Amlodipine … for amlodipine besylate, valsartan, hydrochlorothiazide, (Dafiro … for amlodipine besylate, valsartan, hydrochlorothiazide, (Dafiro … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021irbesartan, losartan, olmesartan, valsartan) Questions & Answers … irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 Page … irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 Page … -
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Opinion/decision on a Paediatric investigation plan (PIP): Copalia, varicella-zoster virus (live, attenuated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Vaccines
PIP number: EMEA-001672-PIP01-14, Route(s) of administration: Subcutaneous use, Intramuscular use, Pharmaceutical form(s): Powder and solvent for suspension for injection
Decision date: 24/11/2014, Last updated: 12/12/2014, Compliance check: XCopalia Copalia amlodipine valsartan varicella-zoster virus (live … virus (live, attenuated) valsartan amlodipine (as amlodipine … -
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Referral: Diovan
valsartan, associated names: Angiosan, Diovane, Tareg, Cordinate, Provas, Dalzad, Rixil, Kalpress Cardio, Diovan Cardio, Miten Cardio, Valsartan Novartis, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 15/12/2009, EC decision date: 19/04/2010, Last updated: 31/05/2010Commission final decision Overview Valsartan (Diovan and associated names … dose of 320 mg since 2006. Valsartan has been approved and marketed … United States since 2007. Valsartan has also been approved for … -
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Referral: Diovan
valsartan, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/11/2008, EC decision date: 16/02/2009, Last updated: 13/03/2009inhibitors. But considering that valsartan given on its own is at least … hard capsules containing valsartan 40, 80, 160 or 320 mg The … inhibitors. But considering that valsartan given on its own is at least … -
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Referral: Diovan
valsartan, associated names: Angiosan, Diovane, Tareg, Cordinate, Provas, Dalzad, Rixil, Kalpress Cardio, Diovan Cardio, Miten Cardio, Valsartan Novartis, Kalpress, Miten, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 15/12/2009, EC decision date: 19/04/2010, Last updated: 31/05/2010Diovan Cardio Miten Cardio Valsartan Novartis Kalpress Miten About … International Non-proprietary Name: Valsartan Procedure No. EMEA/H/A-29 … children until recently. Valsartan (Diovan) is an angiotensin … -
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Referral: Diovan Comp
valsartan, hydrochlorothiazide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/03/2009, EC decision date: 26/05/2009, Last updated: 11/06/2009contains two active substances, valsartan and hydrochlorothiazide Valsartan belongs to a class of medicines … blood pressure to increase. Valsartan works by blocking the effect … names tablets containing valsartan (80, 160 or 320 mg) and hydrochlorothiazide …