1584 results
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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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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: 08/10/2014of the ARBs candesartan or valsartan as add- on therapy to ACE-inhibitors … licensed use of candesartan or valsartan as add-on therapy to ACE … Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … -
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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 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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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn application … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -
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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: 02/09/2022sacubitril / valsartan … Entresto sacubitril / valsartan This is a summary of the … substances sacubitril and valsartan. It is used in adults with … -
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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
substances sacubitril and valsartan. It is used in adults with … 24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 … 97 mg sacubitril / 103 mg valsartan). Neparvis can only be obtained … -
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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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Human medicine European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) (updated)
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 15/01/2015, Revision: 19, Authorised, Last updated: 11/01/2023previously Sevelamer carbonate Zentiva) Nutritional and Metabolic … authorisation) Sevelamer carbonate Zentiva sevelamer carbonate On … product Sevelamer carbonate Zentiva. The marketing authorisation … -
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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 / 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 HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 15/10/2009, Revision: 23, Authorised, Last updated: 21/12/2022substances , 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): Dafiro HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 03/11/2009, Revision: 25, Authorised, Last updated: 20/12/2022substances , 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
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 15/01/2007, Revision: 29, Authorised, Last updated: 11/11/2022substances , amlodipine and valsartan. It is available as tablets … 5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan). What is Copalia used for … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … -
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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: 11/11/2022substances , amlodipine and valsartan. It is available as tablets … 5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan). What is Exforge used for … irbesartan, telmisartan, and valsartan) centrally. ARBs are available … -
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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: XActive 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): 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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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 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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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008Docetaxel Zentiva (previously Docetaxel Winthrop) Docetaxel … Docetaxel Winthrop) Docetaxel Zentiva (previously Docetaxel Winthro … -
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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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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 14, Authorised, Last updated: 21/11/2022
Pregabalin Zentiva Mental Disorders Nervous … report (EPAR) for Pregabalin Zentiva. It explains how the Agency … on how to use Pregabalin Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 9, Authorised, Last updated: 26/08/2022
Aripiprazole Zentiva Schizophrenia Spectrum and … report (EPAR) for Aripiprazole Zentiva. It explains how the Agency … on how to use Aripiprazole Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Riluzole Zentiva
Riluzole, Amyotrophic Lateral Sclerosis
Date of authorisation: 07/05/2012, Revision: 13, Authorised, Last updated: 22/11/2022Riluzole Zentiva Nervous System Diseases Central … report (EPAR) for Riluzole Zentiva. It explains how the The committee … conditions of use for Riluzole Zentiva. What is Riluzole Zentiva? Riluzole Zentiva is a medicine containing …