823 results
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Human medicine European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 26/11/2009,
, Revision: 22, Authorised, Last updated: 16/06/2023
Irbesartan/Hydrochlorothiazide Teva Cardiovascular Diseases Vascular … Authorised irbesartanhydrochlorothiazide Overview This is a summary … part of the EPAR). What is Irbesartan/Hydrochlorothiazide Teva? Irbesartan/Hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Irbesartan Teva (updated)
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 16, Authorised, Last updated: 05/09/2023
Irbesartan Teva Cardiovascular Diseases Vascular … Authorised irbesartan Overview This is a summary … part of the EPAR). What is Irbesartan Teva? Irbesartan … -
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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: 08/10/2014Tolucombi Telmisartan Teva Telmisartan Teva Pharma Tolura Onduarp Twynsta Actelsar … HCT Rasitrio Edarbi Ipreziv Aprovel Ifirmasta (previously Irbesartan Krka Irbesartan … -
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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: 19/03/2021tetrazole group (candesartan, irbesartan, losartan, olmesartan, valsartan … tetrazole group (candesartan, irbesartan, losartan, olmesartan, valsartan … tetrazole group (candesartan, irbesartan, losartan, olmesartan, valsartan … -
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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: 28/09/2022Irbesartan Zentiva (previously Irbesartan Winthrop) Cardiovascular … Authorised irbesartan Overview This is a summary … assessment report (EPAR) for Irbesartan Zentiva. It explains how … -
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Human medicine European public assessment report (EPAR): Irbesartan BMS
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 7, Withdrawn, Last updated: 26/11/2009Irbesartan BMS Hypertension … Irbesartan BMS … Public Statemnet on Irbesartan BMS Withdrawal European … -
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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: 13/04/2023Irbesartan Hydrochlorothiazide Zentiva … Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) Cardiovascular … Authorised irbesartanhydrochlorothiazide Overview This is a summary … -
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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
Ifirmasta (previously Irbesartan Krka) Cardiovascular Diseases Vascular … Authorised irbesartan Overview This is a summary … medicine. active substance irbesartan. It is available as tablets … -
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide BMS
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/01/2007, Revision: 8, Withdrawn, Last updated: 24/11/2009Irbesartan Hydrochlorothiazide BMS Hype … Irbesartan Hydrochlorothiazide BMS … PUBLIC STATEMENT ON Irbesartan Hydrochlorothiazide BMS irbesartan/hydrochlorothiazide) WITHDRAWAL OF THE … -
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Human medicine European public assessment report (EPAR): Karvea
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 46, Authorised, Last updated: 07/07/2023Authorised irbesartan Overview This is a summary … medicine. active substance irbesartan. It is available as tablets … active substance in Karvea, irbesartan, is an ‘angiotensin-II-receptor … -
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Human medicine European public assessment report (EPAR): Aprovel
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 48, Authorised, Last updated: 06/07/2023Authorised irbesartan Overview This is a summary … medicine. active substance irbesartan. It is available as tablets … active substance in Aprovel, irbesartan, is an ‘angiotensin-II-receptor … -
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Human medicine European public assessment report (EPAR): Sabervel
irbesartan, Hypertension
Date of authorisation: 13/04/2012,, Revision: 2, Withdrawn, Last updated: 29/06/2017
Withdrawn irbesartan Overview The marketing authorisation … Sabervel, INN-irbesartan 30 Churchill Place … authorisation for Sabervel (irbesartan) expired on 17 April 2017 … -
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Human medicine European public assessment report (EPAR): Ifirmacombi
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011,, Revision: 15, Authorised, Last updated: 11/07/2023
Authorised irbesartanhydrochlorothiazide Overview This is a summary … medicine. active substances , irbesartan and hydrochlorothiazide … available as tablets (150 mg irbesartan and 12.5 mg hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): CoAprovel
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 14/10/1998, Revision: 48, Authorised, Last updated: 07/07/2023Authorised irbesartanhydrochlorothiazide Overview This is a summary … medicine. active substances , irbesartan and hydrochlorothiazide … tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Karvezide
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 16/10/1998, Revision: 46, Authorised, Last updated: 06/07/2023Authorised irbesartanhydrochlorothiazide Overview This is a summary … medicine. active substances , irbesartan and hydrochlorothiazide … tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide … -
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Referral: Cozaar
irbesartan, associated names: Loortan, Loortan Cardio Start, Cozaar Startpakkle, Cardopal Start, Lorzaar, Lorzaar start, Lorzaar Protect, Pinzaar, Lorzaar Varipharmstart, Lortaan, Neo-Lotan, Losaprex, Cozaar IC, Lortaar IC, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 23/10/2008, EC decision date: 22/01/2009, Last updated: 13/01/2012International Nonproprietary Name: irbesartan Procedure No. EMEA/H/A-29 … irbesartan … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, irbesartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002192-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: XKey facts amlodipine irbesartan Cardiovascular diseasesP/0145/2018EMEA-002192-PIP02-17 … specific waiver for amlodipine / irbesartan (EMEA-002192-PIP02-17) PDF … amlodipine irbesartan … -
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Opinion/decision on a Paediatric investigation plan (PIP): irbesartan, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002352-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/08/2018, Last updated: 17/01/2019, Compliance check: XKey facts irbesartan amlodipine Cardiovascular … product specific waiver for irbesartan / amlodipine (EMEA-002352-PIP01-18 … irbesartan amlodipine … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, irbesartan, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002167-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: XKey facts amlodipine irbesartan hydrochlorothiazide Cardiovascular … specific waiver for amlodipine / irbesartan / hydrochlorothiazide (EMEA … specific waiver for amlodipine / irbesartan / hydrochlorothiazide (EMEA-002167-PIP01-17 … -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn applicati … Pioglitazone Teva Generics: Withdrawal of the … authorisation) Pioglitazone Teva Generics pioglitazone On … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the … application for Clopidogrel Teva Pharma clopidogrel … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva
Telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
Telmisartan Teva Hypertension … Telmisartan Teva … Public statement Telmisartan Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 20, Authorised, Last updated: 21/06/2023
Levetiracetam Teva Nervous System Diseases Central … levetiracetam Overview Levetiracetam Teva is an epilepsy medicine … whole brain. Levetiracetam Teva can also be used as an add-on … -
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Human medicine European public assessment report (EPAR): Tevagrastim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 18, Authorised, Last updated: 14/07/2023
Tevagrastim Agranulocytosis Leukopenia Leukocyte … part of the EPAR). What is Tevagrastim? Tevagrastim is a solution for injection … active substance filgrastim. Tevagrastim is a ‘ A medicine that … -
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
Nevirapine Teva Blood-Borne Infections Communicable … Nevirapine Teva … Public statement Nevirapine Teva (nevirapine) Withdrawal …