98 results
Keyword Entresto Remove keyword
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Summary of opinion: Entresto
sacubitril, valsartan, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023Entresto: Pending EC decision … Entresto … opinion1 (post authorisation) Entresto sacubitril / valsartan On … -
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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: 31/08/2022, Compliance check: XInvented name Entresto Active substance sacubitril … sacubitril / valsartan (Entresto), (EMEA-000316-PIP02-11-M05 … sacubitril / valsartan (Entresto), (EMEA-000316-PIP02-11-M05 … -
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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: XInvented name Entresto Active substance sacubitril … for sacubitril / valsartan (Entresto and associated names), (EMEA-000316-PIP03-20 … for sacubitril / valsartan (Entresto and associated names), (EMEA-000316-PIP03-20 … -
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Human medicine European public assessment report (EPAR): Entresto
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 15, Authorised, Last updated: 02/09/2022Entresto Cardiovascular Diseases Heart … Entresto … Entresto, INN-sacubitril/valsartan … -
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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 … Krka) Ifirmacombi Aprovel Neparvis Exforge Exforge HCT Entresto Dafiro HCT Dafiro Copalia … -
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Press release: New medicine to treat heart failure recommended for approval
CHMP, Last updated: 25/09/2015Entresto brings a new mechanism of … recommended for approval Entresto brings a new mechanism of … marketing authorisation for Entresto (sacubitril/valsartan) for … -
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Human medicine European public assessment report (EPAR): Neparvis
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,
, Revision: 15, Authorised, Last updated: 02/09/2022
This medicine is the same as Entresto, which is already authorised … EU). The company that makes Entresto has agreed that its scientific … This medicine is the same as Entresto, which is already authorised … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023
CHMP, Last updated: 31/03/2023Entresto … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015
CHMP, Last updated: 25/09/2015Entresto … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 29 March - 1 April 2016
CHMP, Last updated: 01/04/2016reference product for Neparvis is Entresto. A A generic medicine is a … -
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 34, Authorised, Last updated: 13/04/2023 -
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Human medicine European public assessment report (EPAR): Revatio
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 49, Authorised, Last updated: 21/03/2023 -
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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
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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: 21/12/2022 -
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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: 20/12/2022 -
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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: 20/12/2022 -
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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: 11/11/2022 -
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Human medicine European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 26/11/2009,, Revision: 21, Authorised, Last updated: 31/08/2022
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Human medicine European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop)
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 28, Authorised, Last updated: 28/09/2022 -
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Human medicine European public assessment report (EPAR): Ifirmacombi
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011,, Revision: 14, Authorised, Last updated: 09/02/2022
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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: 11/11/2022 -
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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: 11/11/2022 -
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Human medicine European public assessment report (EPAR): Irbesartan Teva
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 15, Authorised, Last updated: 06/09/2021
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Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka)
irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008,, Revision: 14, Authorised, Last updated: 03/08/2021
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Human medicine European public assessment report (EPAR): Verquvo
Vericiguat, Heart Failure
Date of authorisation: 16/07/2021,, Authorised, Last updated: 27/07/2021