215 results
-
List item
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 … -
List item
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 … -
List item
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 … -
List item
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Date of authorisation: 19/01/2007, Revision: 7, Withdrawn, Last updated: 26/11/2009Irbesartan BMS Hypertension … Irbesartan BMS … Public Statemnet on Irbesartan BMS Withdrawal European … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015benzoate metformin fluconazole eletriptan rizatriptan ebastine ibuprofen desmopressin aciclovir levetiracetam irbesartan venlafaxine ciprofloxacin cefpodoxime … -
List item
Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018Pharma stopped from supplying irbesartan to the EU … Pharma stopped from supplying irbesartan to the EU … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
CHMP, Last updated: 14/12/2012Fenofibrato Pensa, Fenofibrato Ranbaxy INN fenofibrate … -
List item
Press release: European Medicines Agency recommendation on use of angiotensin-II-receptor antagonists during pregnancy
Last updated: 24/04/2008centrally authorised medicines: irbesartan, telmisartan and valsartan … authorised medicines containing Irbesartan are Aprovel, Karvea Irbesartan BMS and Irbesartan Winthrop … centrally authorised medicines: irbesartan, telmisartan and valsartan … -
List item
Press release: European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive
CHMP, Last updated: 20/10/2011candesartan, eprosartan, irbesartan, losartan, olmesartan, valsartan … and telmisartan. Of these, irbesartan, telmisartan and valsartan … EPAR Ifirmasta (previously Irbesartan Krka): EPAR Imprida: EPAR … -
List item
Press release: Valsartan: review of impurities extended to other sartan medicines
CHMP, Last updated: 21/09/2018039;sartans', namely candesartan, irbesartan, losartan and olmesartan … ‘sartans’, namely candesartan, irbesartan, losartan and olmesartan … the medicine Candesartan, irbesartan, losartan, olmesartan and …