50178 results
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Human medicine European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 30, Authorised, Last updated: 18/12/2020Telmisartan Boehringer Ingelheim Pharma KG) Cardiovascular Diseases Vascular … Telmisartan Boehringer Ingelheim Pharma KG … Telmisartan Boehringer Ingelheim Pharma KG) telmisartan telmisartan … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,
, Revision: 11, Withdrawn, Last updated: 12/12/2018
Zoledronic acid Teva Pharma Osteoporosis Osteitis Deformans Osteoporosis … for Zoledronic acid Teva Pharma has been withdrawn at the … documents Zoledronic acid Teva Pharma : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS)
clopidogrel (as hydrochloride), Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Date of authorisation: 21/09/2009,, Revision: 9, Withdrawn, Last updated: 24/10/2017
Clopidogrel Teva Pharma (previously Clopidogrel HCS) Myocardial … Clopidogrel Teva Pharma (previously Clopidogrel HCS … statement Clopidogrel Teva Pharma Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.
clopidogrel (as hydrobromide), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015
Clopidogrel Teva Pharma B.V. Peripheral Vascular … authorisation for Clopidogrel Teva Pharma B.V. has been withdrawn at … documents Clopidogrel Teva Pharma B.V. : EPAR - Summary for … -
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Human medicine European public assessment report (EPAR): Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 2, Withdrawn, Last updated: 05/12/2005teplase Boehringer Ingelheim Pharma GmbH Co. KG Myocardial … Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG has been withdrawn … gt;Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KGEMEA/H/C/000307tenecteplasetenecteplaseMyocardial … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 2, Authorised, Last updated: 08/12/2021Budesonide/Formoterol Teva Pharma B.V. Lung Diseases, Obstructive Lung … Budesonide/Formoterol Teva Pharma B.V. is a medicine used for … Budesonide/Formoterol Teva Pharma B.V. is also used to relieve … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017Budesonide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at … Budesonide/Formoterol Teva Pharma B.V.: EPAR - Summary for … -
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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: 08/10/2014recommendations made by the Agency’s Pharmacovigilance Risk Assessment Committee … artan Teva Telmisartan Teva Pharma Tolura Onduarp Twynsta Actelsar … Telmisartan Boehringer Ingelheim Pharma KG) Micardis Pritor Telmisartan … -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 16/12/2022Clinical pharmacology and pharmacokinetics: questions and answers … issues related to clinical pharmacology and pharmacokinetics. … comments) 31 May 2010 Agreed by Pharmacokinetics Working Party (PKWP) June …
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ICH E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Scientific guideline
Last updated: 01/11/2007Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding … Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding … Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding …
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Pharmacovigilance: Overview
Last updated: 21/04/2022Pharmacovigilance: Overview … information can be found under 'Pharmacovigilance - Overview' Pharmacovigilance is the science and activities … information can be found under 'Pharmacovigilance - Overview' …