733 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: 20, Authorised, Last updated: 09/09/2021
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
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 15, Authorised, Last updated: 06/09/2021
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: 26, Authorised, Last updated: 06/09/2021Irbesartan 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): 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 Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 30, Authorised, Last updated: 07/04/2022Irbesartan 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): 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: 43, Authorised, Last updated: 16/02/2022Authorised 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: 45, Authorised, Last updated: 16/02/2022Authorised 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: 14, Authorised, Last updated: 09/02/2022
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): Karvezide
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 16/10/1998, Revision: 43, Authorised, Last updated: 16/02/2022Authorised 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): CoAprovel
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 14/10/1998, Revision: 45, Authorised, Last updated: 16/02/2022Authorised 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 … authorisation for Telmisartan Teva has been withdrawn at the … Summary documents Telmisartan Teva : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 18, Authorised, Last updated: 09/06/2022
Imatinib Teva Leukemia, Myelogenous, Chronic … report (EPAR) for Imatinib Teva. It explains how the Agency … advice on how to use Imatinib Teva. For practical information … -
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Human medicine European public assessment report (EPAR): Desloratadine Teva (updated)
desloratadine, Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Date of authorisation: 24/11/2011,, Revision: 18, Authorised, Last updated: 09/06/2022
Desloratadine Teva Respiratory Tract Diseases Nose … EPAR) for Desloratadine Teva. It explains how the The committee … of use for Desloratadine Teva. What is Desloratadine Teva? Desloratadine Teva is a medicine containing … -
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Human medicine European public assessment report (EPAR): Temozolomide Teva
temozolomide, Glioma; Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 21, Authorised, Last updated: 18/02/2022
Temozolomide Teva Cancer Neuroectodermal … Temozolomide Teva … Temozolomide Teva, INN: temozolomide EMA/523990/2014 …