368 results
Keyword HCT Remove keyword
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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 … hydrochlorothiazide, (Imprida HCT), (EMEA-000399-PIP01-08) in … EMEA/24175/2009 Generic Imprida HCT: EPAR 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: XInvented name Copalia HCT Active substance valsartan … hydrochlorothiazide, (Copalia HCT), (EMEA-000397-PIP01-08) in … hydrochlorothiazide, (Copalia HCT), (EMEA-000397-PIP01-08) in … -
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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: XInvented name Dafiro HCT Active substance valsartan … hydrochlorothiazide, (Dafiro HCT), (EMEA-000398-PIP01-08) in … hydrochlorothiazide, (Dafiro HCT), (EMEA-000398-PIP01-08) in … -
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Human medicine European public assessment report (EPAR): Actelsar HCT
telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,
, Revision: 14, Authorised, Last updated: 24/08/2022
Actelsar HCT Hypertension Vascular Diseases Cardiovascular … report (EPAR) for Actelsar HCT. It explains how the Agency … advice on how to use Actelsar HCT. For practical information … -
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Human medicine European public assessment report (EPAR): Rasilez HCT
aliskiren, hydrochlorothiazide, Hypertension
Date of authorisation: 16/01/2009, Revision: 17, Withdrawn, Last updated: 20/05/2022Rasilez HCT Cardiovascular Diseases Vascular … authorisation for Rasilez HCT has been withdrawn at the … Summary documents Rasilez HCT : EPAR - Medicine overview … -
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Human medicine European public assessment report (EPAR): Sprimeo HCT
aliskiren, hydrochlorothiazide, Hypertension
Date of authorisation: 23/06/2011, Withdrawn, Last updated: 28/08/2012Sprimeo HCT Hypertension … authorisation for Sprimeo HCT has been withdrawn at the … Summary documents Sprimeo HCT : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Riprazo HCT
aliskiren, hydrochlorothiazide, Hypertension
Date of authorisation: 13/04/2011, Withdrawn, Last updated: 20/09/2012Riprazo HCT Hypertension … authorisation for Riprazo HCT has been withdrawn at the … Summary documents Riprazo HCT : EPAR - Summary for the … -
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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: 21/12/2022Exforge HCT Cardiovascular Diseases Vascular … report (EPAR) for Exforge HCT. It explains how the The committee … conditions of use for Exforge HCT. What is Exforge HCT? Exforge HCT is a medicine that contains … -
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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: 20/12/2022Copalia HCT Cardiovascular Diseases Vascular … Copalia HCT … for the public Copalia HCT amlodipine / valsartan … -
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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: 20/12/2022Dafiro HCT Vascular Diseases Cardiovascular … the EPAR). What is Dafiro HCT? Dafiro HCT is a medicine that contains … 10/320/25 mg. What is Dafiro HCT used for? Dafiro HCT is used to treat essential … -
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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: 22/10/2012Imprida HCT Hypertension … authorisation for Imprida HCT has lapsed because it has … Summary documents Imprida HCT : EPAR - Summary for the … -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014Pharma Tolura Onduarp Twynsta Actelsar HCT Kinzalkomb MicardisPlus PritorPlus Copalia … disPlus PritorPlus Copalia HCT Dafiro HCT Exforge HCT Rasilamlo Rasilez Rasilez … -
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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: 19/03/2021Krka) Ifirmacombi Aprovel Neparvis Exforge Exforge HCT Entresto Dafiro HCT Dafiro Copalia HCT Copalia Amlodipine / Valsartan … -
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Referral: Tritazide
ramipril, hydrochlorothiazide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 14/04/2009passageways. Hydrochlorothiazide (HCTZ) is a diuretic. It works … Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide … Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark … -
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Press release: European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study
CHMP, Last updated: 22/12/2011Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Riprazo, Riprazo HCT, Sprimeo, Sprimeo HCT. Some of these medicines (Rasilamlo … Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Riprazo, Riprazo HCT, Sprimeo, Sprimeo HCT. Some of these medicines … -
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Press release: European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines
CHMP, Last updated: 17/02/2012Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Riprazo, Riprazo HCT, Sprimeo and Sprimeo HCT. Some of these medicines (Rasilamlo … Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Riprazo, Riprazo HCT, Sprimeo and Sprimeo HCT. Some of these medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013
PRAC, Last updated: 17/05/2013PRAC recommendation Actelsar HCT: EPAR Aprovel: EPAR CoAprovel … EPAR Copalia: EPAR Copalia HCT: EPAR Dafiro: EPAR Dafiro HCT: EPAR Edarbi: EPAR Exforge … EPAR Exforge: EPAR Exforge HCT: EPAR Ifirmacombi: EPAR Ifirmasta … -
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Press release: European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive
CHMP, Last updated: 20/10/2011EPAR Copalia: EPAR Copalia HCT: EPAR Dafiro: EPAR Dafiro HCT: EPAR Exforge: EPAR Exforge HCT: EPAR Ifirmacombi: EPAR Ifirmasta … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011
CHMP, Last updated: 21/10/2011EPAR Copalia: EPAR Copalia HCT: EPAR Dafiro: EPAR Dafiro HCT: EPAR Exforge: EPAR Exforge HCT: EPAR Glubrava: EPAR Glustin … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 2012
CHMP, Last updated: 17/02/2012Sprimeo, Rasilamlo, Rasilez HCT, Riprazo HCT, Sprimeo HCT, Rasitrio aliskiren Novartis … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2013
CHMP, Last updated: 28/06/2013Copalia HCT INN amlodipine / valsartan … -
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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: 11/06/2009Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix, Mitten … Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011
CHMP, Last updated: 21/01/2011Riprazo HCT … authorisation for Riprazo HCT (aliskiren/hydrochlorothiazide … hypertension. The review for Riprazo HCT began on 21 November 2010 … -
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Press release: European Medicines Agency recommends new contraindication and warning for Rasilez and other aliskiren medicines
Last updated: 19/02/2009hydrochlorothiazide as Rasilez HCT. The Product Information for … hydrochlorothiazide as Rasilez HCT. The Product Information … -
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Referral: Cozaar Comp
Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/04/2008, EC decision date: 03/09/2008, Last updated: 25/09/2008cascade. Hydrochlorothiazide (HCTZ) is a thiazide diuretic which … cascade. Hydrochlorothiazide (HCTZ) is a thiazide diuretic which …