16333 results
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Sunset-clause monitoring: questions and answers
Last updated: 01/01/2016Sunset-clause monitoring: questions and … 2005 - Application of the "Sunset Clause" in the Review of the Pharmaceutical Legislation to Medicinal … e.g. new strengths, new pharmaceutical forms,…) authorised for …
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Referral: Budesonide SUN
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/06/2020, EC decision date: 19/08/2020, Last updated: 16/09/2020Budesonide SUN … authorisation for Budesonide Sun (budesonide, nebuliser suspension … authorisation of Budesonide Sun and associated names cannot … -
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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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National expert: Katarina Sundberg, Medical Products Agency (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 24.47 KB | PDF
Katarina Sundberg … Katarina Sundberg … Vitae Personal information Katarina Sundberg Work experience … -
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National expert: Andreas Sundgren, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 28.54 KB | PDF
Andreas Sundgren … Andreas Sundgren … Vitae Personal information Andreas Sundgren Work experience … -
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National expert: Kaisa Sunela, Finnish Medicines Agency (updated)
- Declaration of interests - 51.02 KB | PDF
- Curriculum Vitae - 34.87 KB | PDF
Kaisa Sunela … Kaisa Sunela … Vitae Personal information Kaisa Sunela Work experience … -
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National expert: Yuansheng Sun, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 23.31 KB | PDF
Yuansheng Sun … Yuansheng Sun … Vitae Personal information Yuansheng Sun Work experience … -
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National expert: Anna Sundlöv, Medical Products Agency (updated)
- Declaration of interests - 44.7 KB | PDF
- Curriculum Vitae - 35.46 KB | PDF
Anna Sundlöv … Anna Sundlöv … Vitae Personal information Anna Sundlöv Work experience … -
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Sunset clause monitoring: Regulatory and procedural guidance
Last updated: 01/01/2016Sunset clause monitoring: Regulatory … SOP/H/3128 Application of the "Sunset Clause" in the Review of the Pharmaceutical Legislation to Medicinal … 726/2004 start to apply Q&A: Sunset Clause monitoring …
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National expert: Hildrun Sundseth, European Medicines Agency (updated)
- Declaration of interests - 40.55 KB | PDF
- Curriculum Vitae - 24.17 KB | PDF
Hildrun Sundseth … Hildrun Sundseth … Vitae Personal information Hildrun Sundseth Work experience … -
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National expert: Per Anders Sundström, Medical Products Agency (updated)
- Declaration of interests - 39.73 KB | PDF
- Curriculum Vitae - 41.24 KB | PDF
Per Anders Sundström … Per Anders Sundström … Vitae Personal information Per Anders Sundström Work experience … -
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Sunitinib product-specific bioequivalence guidance
Last updated: 07/07/2015Sunitinib product-specific bioequivalence … Sunitinib product-specific bioequivalence … Sunitinib hard capsules 12.5, 25, 37.5 …
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Notifying a change of marketing status and sunset clause (veterinary medicines)
Last updated: 29/07/2021change of marketing status and sunset clause (veterinary medicines … change of marketing status and sunset clause (veterinary medicines …
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Press release: Scenesse recommended for rare disease that causes intolerance to sunlight
CHMP, Last updated: 24/10/2014that causes intolerance to sunlight … that causes intolerance to sunlight … that causes intolerance to sunlight Patients involved in discussions … -
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News: European Medicines Agency website unavailable Sunday 1 December 2013
Last updated: 29/11/2013Agency website unavailable Sunday 1 December 2013 … between 9:00 and 17:00 on Sunday 1 December 2013 due to essential … -
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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 … Pharmacovigilance: Overview … Medicines Division EMA pharmacovigilance system manual Version 1.3 …
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Eighth stakeholders forum on the implementation of the pharmacovigilance legislation: Building on two years of operation
European Medicines Agency, London, UK, 15/09/2014, Last updated: 22/09/2014the implementation of the pharmacovigilance legislation: Building on … the implementation of the pharmacovigilance legislation: Building on … Inspections and Human Medicines Pharmacovigilance Division Agenda – Eighth … -
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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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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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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 …