16375 results
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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, Revision: 4, Withdrawn, Last updated: 03/02/2015
Clopidogrel Teva Pharma B.V. Peripheral Vascular … authorisation for Clopidogrel Teva Pharma B.V. has been withdrawn at … documents Clopidogrel Teva Pharma B.V. : EPAR - Summary for … -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Date of authorisation: 23/02/2001, Revision: 2, Withdrawn, Last updated: 05/12/2005teplase Boehringer Ingelheim Pharma GmbH Co. KG Myocardial … Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG has been withdrawn … gt;Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KGEMEA/H/C/000307tenecteplasetenecteplaseMyocardial … -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Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017Budesonide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at … Budesonide/Formoterol Teva Pharma B.V.: EPAR - Summary for … -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 … Clinical pharmacology and pharmacokinetics: questions and answers …
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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' …
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Pharmacovigilance: Regulatory and procedural guidance
Last updated: 29/04/2016Pharmacovigilance: Regulatory and procedural … Pharmacovigilance: Regulatory and procedural … variations to an existing pharmacovigilance system as described in the …
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Pharmacovigilance: post-authorisation
Last updated: 28/03/2017Pharmacovigilance: post-authorisation … Pharmacovigilance: post-authorisation …
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Pharmacovigilance: research and development
Last updated: 28/03/2017Pharmacovigilance: research and development … the sections below: Good pharmacovigilance practices : see Modules I Pharmacovigilance systems) and II Pharmacovigilance system master file) Patient …
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Pharmacovigilance: marketing authorisation
Last updated: 28/03/2017Pharmacovigilance: marketing authorisation … information can be found under 'Pharmacovigilance - Overview' pharmacovigilance activities designed to further … information can be found under 'Pharmacovigilance - Overview' …
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Clinical pharmacology and pharmacokinetics
Last updated: 26/03/2010Clinical pharmacology and pharmacokinetics … Clinical pharmacology and pharmacokinetics …
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Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use” - Scientific guideline
Last updated: 17/02/2023Control of impurities of pharmacopoeial substances: compliance with … compliance with the European Pharmacopoeia general monograph “Substances … monograph “Substances for Pharmaceutical Use” and general chapter …
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Referral: Pharmasin
tylosin tartrate, associated names: Tylmasin, Article 33
Status: European Commission final decision, opinion/position date: 12/03/2009, EC decision date: 08/01/2010, Last updated: 30/04/2010Pharmasin … Recommendation provided by Pharmacovigilance Risk Assessment Committee … decentralised procedure for Pharmasin 100% W/W Water Soluble Granules … -
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Non-clinical: pharmacology and safety pharmacology
Last updated: 25/05/2016Non-clinical: pharmacology and safety pharmacology … guidelines on non-clinical pharmacology help medicine developers …
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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific convention - European Union (EU) healthcare databases for pan-EU pharmacoepidemiological research
London, UK, 25/11/2008, Last updated: 25/11/2008opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific convention - European … healthcare databases for pan-EU pharmacoepidemiological research … opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific convention - European … -
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Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics) - Scientific guideline
Last updated: 21/10/1999Development pharmaceutics for biotechnological and … for guidance on development pharmaceutics) - Scientific guideline … Development pharmaceutics for biotechnological and …
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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
Last updated: 24/11/2017opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance … opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance …
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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance plenary meeting
European Medicines Agency, London, UK, 23/11/2011, Last updated: 29/07/2011opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance plenary meeting … European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is being held on … European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Plenary meeting … -
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Excellence in pharmacovigilance: Clinical trials and post-marketing
Zagreb, Croatia, from 03/10/2011 to 07/10/2011, Last updated: 30/06/2011Excellence in pharmacovigilance: Clinical trials and post-mark … Registration form Excellence in Pharmacovigilance: Clinical Trials and Post … -
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ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline
Last updated: 01/06/2001ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline … ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline … S 7 A Safety Pharmacology Studies for Human Pharmaceuticals European Medicines …
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ICH S3B Pharmacokinetics: repeated dose tissue distribution studies - Scientific guideline
Last updated: 30/11/1994ICH S3B Pharmacokinetics: repeated dose tissue distribution … ICH S3B Pharmacokinetics: repeated dose tissue distribution … S 3 B Pharmacokinetics: Repeated Dose Tissue Distribution …
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Pharmacovigilance assessments: challenges and solutions for pharmacovigilance assessors
European Medicines Agency, Amsterdam, The Netherlands, from 11/11/2019 to 12/11/2019, Last updated: 03/10/2019Pharmacovigilance assessments: challenges and … challenges and solutions for pharmacovigilance assessors … pharmacovigilance assessors … -
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Referral: Pharmaceutics International Inc.
sodium phenylbutyrate, progesterone, dutasteride, colecalciferol, associated names: Ammonaps, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/09/2016, EC decision date: 05/12/2016, Last updated: 14/12/2016Pharmaceutics International Inc … Pharmaceutics International Art 31_PHC_post-EC … EMA/826770/2016 Corr.* Pharmaceutics International Inc, US: supply …