491 results
Keyword Amlodipine Remove keyword
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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: 10, Authorised, Last updated: 30/09/2022
Amlodipine / Valsartan Mylan Cardiovascular … Authorised amlodipinevalsartan Overview This is a summary … assessment report (EPAR) for Amlodipine/Valsartan Mylan. It explains how the … -
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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: 11/11/2022Authorised amlodipinevalsartan Overview This is a summary … medicine. active substances , amlodipine and valsartan. It is available … available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg … -
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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: 11/11/2022Authorised amlodipinevalsartan Overview This is a summary … medicine. active substances , amlodipine and valsartan. It is available … available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg … -
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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Date of authorisation: 17/01/2007, Revision: 20, Withdrawn, Last updated: 11/05/2017Withdrawn amlodipinevalsartan Overview The marketing authorisation … gt;ImpridaEMEA/H/C/000775valsartanamlodipine (as amlodipine besilate)amlodipinevalsartanHypertensionC09DB01 … adequately controlled on amlodipine or valsartan monotherapy … -
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Veterinary medicine European public assessment report (EPAR): Lodipressin
Amlodipine besilate, Cats
Date of refusal: 08/07/2015, Refused, Last updated: 29/04/2016Refused amlodipine Overview On 15 January 2015 … contains the active substance amlodipine besilate. It was to be available … Lodipressin expected to work? Amlodipine is a calcium channel blocker … -
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Human medicine European public assessment report (EPAR): Twynsta
telmisartan, amlodipine, Hypertension
Date of authorisation: 07/10/2010, Revision: 12, Authorised, Last updated: 10/01/2022substances , telmisartan and amlodipine. It is available as tablets … 40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg … Twynsta, INN-Telmisartan, Amlodipine 30 Churchill Place … -
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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 … Dafiro, INN - amlodipine/valsartan 30 Churchill Place … for the public Dafiro amlodipine / valsartan This is a summary … -
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Human medicine European public assessment report (EPAR): Rasilamlo
aliskiren, amlodipine, Hypertension
Date of authorisation: 14/04/2011, Revision: 7, Withdrawn, Last updated: 28/03/2017controlled with aliskiren or amlodipine used alone. More information … on Rasilamlo (aliskiren / amlodipine): Withdrawal of the marketing … for Rasilamlo (aliskiren / amlodipine) in the European Union (EU … -
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Human medicine European public assessment report (EPAR): Rasitrio
aliskiren, amlodipine, hydrochlorothiazide, Hypertension
Date of authorisation: 22/11/2011, Revision: 1, Withdrawn, Last updated: 20/09/2012combination of aliskiren, amlodipine and hydrochlorothiazide given … Rasitrio aliskiren amlodipine hydrochlorothiazide aliskir … rochlorothiazide aliskiren amlodipine hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Copalia HCT
amlodipine, valsartan, hydrochlorothiazide, Hypertension
Date of authorisation: 03/11/2009, Revision: 23, Authorised, Last updated: 20/12/2022amlodipine / valsartan / hydrochlorothia … the public Copalia HCT amlodipine / valsartan / hydrochlorothiazide … three active substances, 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: 21/12/2022Authorised amlodipine besilatevalsartanhydrochlorothiazide … medicine. active substances , amlodipine, valsartan and hydrochlorothiazide … available as tablets containing amlodipine, valsartan and hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Dafiro HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 03/11/2009, Revision: 25, Authorised, Last updated: 20/12/2022Authorised amlodipine besilatevalsartanhydrochlorothiazide … medicine. active substances , amlodipine, valsartan and hydrochlorothiazide … available as tablets containing amlodipine, valsartan and hydrochlorothiazide … -
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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: XActive substance valsartan Amlodipine besilate Therapeutic area … proposed product-specific waiver Amlodipine (besylate) / valsartan for … product- specific waiver Amlodipine (besylate) / valsartan for … -
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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: 22/10/2012Withdrawn amlodipinevalsartanhydrochlorothiazide Overview The marketing authorisation … gt;Imprida HCTEMEA/H/C/001161amlodipinevalsartanhydrochlorothiazideamlodipinevalsartanhydrochlorothiazideHypertensionC09DX01 Publication details … controlled on the combination of amlodipine, valsartan and hydrochlorothiazide … -
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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: Xvalsartan hydrochlorothiazide Amlodipine besilate Cardiovascular diseasesP/16/2009EMEA-000399-PIP01-08 … product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide … product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide … -
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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: Xvalsartan hydrochlorothiazide Amlodipine besilate Therapeutic area … product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide … product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide … -
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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: Xvalsartan hydrochlorothiazide Amlodipine besilate Therapeutic area … product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide … product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide … -
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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 … live, attenuated) valsartan amlodipine (as amlodipine besilate … -
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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: 19/03/2021HCT Dafiro Copalia HCT Copalia Amlodipine / Valsartan Mylan CoAprovel Karvezide Karvea Irbesartan/Hydrochlorothiazide … HCT Dafiro Copalia HCT Copalia Amlodipine / Valsartan Mylan CoAprove … CoAprovel valsartan candesartan irbesartan losartan olmesartan irbesartan hydrochlorothiazide irbesartan irbesartan hydrochlorothiazide irbesartan irbesartan irbesartan hydrochlorothiazide irbesartan irbesartan hydrochlorothiazide irbesartan sacubitril valsartan amlodipine valsartan … -
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Human medicine European public assessment report (EPAR): Onduarp
telmisartan, Hypertension
Date of authorisation: 24/11/2011, Revision: 2, Withdrawn, Last updated: 02/04/2014adequately controlled on amlodipine. … calcium channel blocker, amlodipine. Onduarp had been approved … adequately controlled on amlodipine. Replacement therapy Adult … -
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Referral: Amlodipin Woerwag
amlodipine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/01/2004, EC decision date: 27/04/2004, Last updated: 30/06/2004Amlodipin Woerwag … Commission final decision Overview Amlodipine is indicated for use in hypertension … for mutual recognition of amlodipine maleate on the basis of the … -
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Referral: Norvasc
amlodipine, associated names: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/07/2011, EC decision date: 07/10/2011, Last updated: 29/03/2012contains the active substance amlodipine. It has been used to treat … blood flow to the heart). Amlodipine is a calcium channel blocker … of calcium into the cells, amlodipine prevents the blood vessel … -
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Referral: Talam
amlodipine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/01/2004, EC decision date: 27/04/2004, Last updated: 30/06/2004Commission final decision Overview Amlodipine is indicated for use in hypertension … for mutual recognition of amlodipine maleate on the basis of the … Non-Proprietary Name (INN): Amlodipine: Background information and … -
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Referral: Pidolma
amlodipine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/01/2004, EC decision date: 27/04/2004, Last updated: 27/04/2004Commission final decision Overview Amlodipine is indicated for use in hypertension … for mutual recognition of amlodipine maleate on the basis of the … Non-Proprietary Name (INN): Amlodipine: Background information and … -
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Referral: Amlovita
amlodipine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/01/2004, EC decision date: 26/04/2004, Last updated: 26/04/2004Commission final decision Overview Amlodipine is indicated for use in hypertension … for mutual recognition of amlodipine maleate on the basis of the … Non-Proprietary Name (INN): Amlodipine: Background information and …