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Similar biological medicinal products containing recombinant erythropoietins
Last updated: 23/07/2018Keywords Erythropoietin, Epoetin, recombinant biological medicinal … recombinant human erythropoietin (epoetin)-containing medicinal products claiming … expression system and termed epoetin. All …
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National expert: Dimitar Roussinov, Bulgarian Drug Agency (updated)
- Declaration of interests - 80.55 KB | PDF
- Curriculum Vitae - 73.15 KB | PDF
Hospira UK Limited Retacrit (epoetin zeta) Post-Autorization Safety … -
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Human medicines highlights: Issue 27 - April 2011
Last updated: 06/05/2011Epostim ( epoetin alfa ) Intended for the treatment …
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PRAC recommendations on safety signals (updated)
Last updated: 26/10/2020 -
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PDCO: Agendas, minutes and meeting reports
Last updated: 03/09/2020 -
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Newsletters
Last updated: 04/09/2020 -
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PRAC: Agendas, minutes and highlights
Last updated: 14/06/2019 -
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Annual reports and work programmes
Last updated: 15/06/2020 -
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PRAC: meeting archive 2012-2013
Last updated: 13/05/2016 -
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PRAC: Committee agendas, minutes and meeting highlights report archive 2012-2013
Last updated: 01/01/2015 -
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PRAC: meeting archive 2014-2015
Last updated: 13/05/2016 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013 -
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Monthly reports of the CHMP Pharmacovigilance Working Party
Last updated: 31/12/2009 -
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Sampling and testing
Last updated: 28/03/2019 -
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Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Last updated: 09/01/2015 -
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Similar biological medicinal products
Last updated: 30/10/2005 -
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Leaflets
Last updated: 23/09/2016 -
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CHMP: meeting archive 2016-2018
Last updated: 26/02/2020 -
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Immunogenicity assessment of biotechnology-derived therapeutic proteins
Last updated: 13/12/2007 -
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Needs for paediatric medicines
Last updated: 11/05/2016 -
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PDCO: Committee meeting report archive 2007-2011
Last updated: 16/09/2013 -
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Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
Last updated: 03/06/2014 -
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Formulations of choice for the paediatric population
Last updated: 28/07/2006 -
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CHMP: meeting archive 2010-2012
Last updated: 17/12/2013 -
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CHMP: meeting archive 2013-2015
Last updated: 12/05/2016