791 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: 21, Authorised, Last updated: 31/08/2022
Irbesartan/Hydrochlorothiazide Teva Cardiovascular Diseases Vascular … Irbesartan/Hydrochlorothiazide Teva … in the EU2, three of them (irbesartan, telmisartan, and valsartan … -
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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: 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): 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: 33, Authorised, Last updated: 28/09/2022Irbesartan Hydrochlorothiazide Zentiva … Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) Cardiovascular … Irbesartan Hydrochlorothiazide Zentiva … -
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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 (updated)
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 45, Authorised, Last updated: 02/02/2023irbesartan … in the EU2, three of them (irbesartan, telmisartan, and valsartan … candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan … -
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Human medicine European public assessment report (EPAR): Aprovel
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 46, Authorised, Last updated: 12/10/2022irbesartan … in the EU2, three of them (irbesartan, telmisartan, and valsartan … candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan … -
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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): Karvezide (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 16/10/1998, Revision: 44, Authorised, Last updated: 02/02/2023irbesartan / hydrochlorothiazide … in the EU2, three of them (irbesartan, telmisartan, and valsartan … candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan … -
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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): CoAprovel
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 14/10/1998, Revision: 45, Authorised, Last updated: 16/02/2022irbesartan / hydrochlorothiazide … in the EU2, three of them (irbesartan, telmisartan, and valsartan … candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan … -
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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): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 29, Authorised, Last updated: 22/11/2022
Olanzapine Teva Schizophrenia Spectrum and … EPAR). What is Olanzapine Teva? Olanzapine Teva is a medicine containing … in the mouth. Olanzapine Teva is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 13, Authorised, Last updated: 17/11/2022
Lamivudine Teva Infections Communicable … Lamivudine Teva … for the public Lamivudine Teva lamivudine This is a summary … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
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 …