43 results
Keyword Condrosulf Unidie Remove keyword
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Withdrawn application: Erbitux
cetuximab, date of withdrawal: 17/09/2012, Post-authorisation, Last updated: 22/11/2012 -
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Opinion on medicine for use outside EU: Fexinidazole Winthrop
fexinidazole, Trypanosomiasis, African, ATC code: P01CA03 Opinion number: H-W-2320, Positive opinion Opinion date: 15/11/2018, Last updated: 22/12/2022 -
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Referral: Metformin and metformin-containing medicines
metformin, associated names: Xigduo, Vipdomet, Velmetia, Synjardy, Ristfor, Komboglyze, Jentadueto, Janumet, Icandra (previously Vildagliptin / metformin hydrochloride Novartis), Glubrava, Eucreas, Efficib, Ebymect, Competact, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/10/2016, EC decision date: 12/12/2016, Last updated: 21/12/2016 -
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Referral: Budesonide Sandoz
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/02/2009, EC decision date: 07/05/2009, Last updated: 25/06/2009 -
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Conduct of efficacy studies for non-steroidal anti-inflammatory drugs (NSAIDs) - Scientific guideline
Last updated: 26/07/2021 -
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Use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline
Last updated: 20/02/2014 -
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Clinical development of medicinal products intended for the treatment of pain - Scientific guideline
Last updated: 22/12/2016 -
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Benefit-risk methodology
Last updated: 18/06/2018 -
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Pharmacokinetic and clinical evaluation of modified-release dosage forms - Scientific guideline
Last updated: 29/10/2019 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Joint workshop with representatives from patients', consumers' and healthcare professionals' organisations: Regulatory and methodological standards to improve benefit-risk evaluation of medicines
European Medicines Agency, London, UK, 26/02/2014, Last updated: 28/04/2014 -
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News: Guideline on the clinical development of medicines for the treatment of pain released for public consultation
CHMP, Last updated: 30/05/2013 -
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Workshop on clinical development and scientific advice in ophthalmology
European Medicines Agency, London, from 27/10/2011 to 28/10/2011, Last updated: 04/07/2011 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development
Last updated: 16/12/2022 -
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Committee for Advanced Therapies-European Society for Gene and Cell Therapy satellite workshop - Advanced-therapy medicinal products
Brighton, UK, 27/10/2011, Last updated: 06/02/2012 -
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European Medicines Agency-Committee for Advanced Therapies stakeholders workshop
European Medicines Agency, London, UK, 12/01/2012, Last updated: 02/02/2012 -
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Spinal muscular atrophy workshop
European Medicines Agency, London, 11/11/2016, Last updated: 05/12/2016 -
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Workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis
European Medicines Agency, London, UK, 17/10/2013, Last updated: 07/10/2013