2636 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 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 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 Teva is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Sunitinib Accord
sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Date of authorisation: 11/02/2021,
, , Revision: 1, Authorised, Last updated: 14/12/2021
Sunitinib Accord Cancer Neoplasms Neoplasms … Sunitinib Accord … EMA/18013/2021 EMEA/H/C/005419 Sunitinib Accord sunitinib) An overview of Sunitinib Accord and why it is authorised … -
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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Date of authorisation: 19/01/2007, Revision: 7, Withdrawn, Last updated: 26/11/2009Irbesartan BMS Hypertension … Irbesartan BMS … Public Statemnet on Irbesartan BMS Withdrawal European … -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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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): Aprovel
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 47, Authorised, Last updated: 16/02/2023irbesartan … 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): Karvea
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): Sutent
sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Date of authorisation: 19/07/2006, Revision: 39, Authorised, Last updated: 13/08/2021sunitinib … Sutent; INN-sunitinib 30 Churchill Place … for the public Sutent sunitinib This is a summary of the … -
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Human medicine European public assessment report (EPAR): Karvezide (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 16/10/1998, Revision: 45, Authorised, Last updated: 16/05/2023Authorised 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): CoAprovel (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 14/10/1998, Revision: 47, Authorised, Last updated: 16/05/2023Authorised 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): 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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Opinion/decision on a Paediatric investigation plan (PIP): Sutent, sunitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000342-PIP01-08-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: V, 29/06/2018name Sutent Active substance sunitinib Therapeutic area Oncology … Sutent Sutent sunitinib sunitinib sunitinib … -
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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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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: 08/10/2014HCT Rasitrio Edarbi Ipreziv Aprovel Ifirmasta (previously Irbesartan Krka Irbesartan Teva Irbesartan Zentiva (previously … -
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Withdrawn application: Sutent
sunitinib, date of withdrawal: 26/06/2018, Post-authorisation, Last updated: 17/08/2018authorisation for Sutent (sunitinib) On 26 June 2018, Pfizer … contains the active substance sunitinib. Further information on … active substance in Sutent, sunitinib, is a protein kinase inhibitor … -
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Withdrawn application: Docetaxel SUN
docetaxel, date of withdrawal: 06/06/2016, Initial authorisation, Last updated: 29/09/2016Docetaxel SUN: Withdrawn application … application for Docetaxel Sun (docetaxel) On 6 June … docetaxel) On 6 June 2016, Sun Pharmaceutical Industries … -
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Withdrawn application: Topotecan SUN
topotecan, date of withdrawal: 03/01/2011, Initial authorisation, Last updated: 23/02/2011Topotecan SUN: Withdrawn application … Topotecan SUN: Withdrawal of the marketing … application for Topotecan SUN (topotecan) On 3 January … -
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Withdrawn application: Repaglinide Sun
repaglinide, date of withdrawal: 25/03/2010, Initial authorisation, Last updated: 15/05/2010Repaglinide Sun: Withdrawn application … Repaglinide Sun: Withdrawal of the marketing … application for Repaglinide Sun (repaglinide) On 23 March … -
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Withdrawn application: Doxorubicin SUN
doxorubicin, date of withdrawal: 20/07/2011, Initial authorisation, Last updated: 26/09/2011Doxorubicin SUN: Withdrawn application … application for Doxorubicin SUN (doxorubicin) On 20 Jul … doxorubicin) On 20 Jul 2011, Sun Pharmaceutical Industries … -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023Metformin hydrochloride Sun: Pending EC decision … Metformin hydrochloride Sun … Sitagliptin/Metformin hydrochloride Sun sitagliptin / metformin … -
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Human medicine European public assessment report (EPAR): Sunlenca
Lenacapavir sodium, HIV Infections
Date of authorisation: 17/08/2022,, Authorised, Last updated: 25/08/2022
Sunlenca Blood-Borne Infections Communicable … Sunlenca … EMA/624383/2022 EMEA/H/C/005638 Sunlenca (lenacapavir) An overview …