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Opinion/decision on a Paediatric investigation plan (PIP): Exjade, deferasirox
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001103-PIP01-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet, Granules
Decision date: 30/06/2016, Last updated: 21/12/2016, Compliance check: V, 14/10/2016investigation plan for deferasirox (Exjade), (EMEA-001103-PIP01-10-M03 … investigation plan for deferasirox (Exjade), (EMEA-001103-PIP01-10-M03 … investigation plan for deferasirox (Exjade), dispersible tablet, film- coated … -
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Human medicine European public assessment report (EPAR): Exjade (updated)
deferasirox, beta-Thalassemia, Iron Overload
Date of authorisation: 28/08/2006,
, Revision: 45, Authorised, Last updated: 20/07/2020
Exjade, INN-deferasirox 7 … indication application for Exjade (deferasirox) On 25 April … application to modify the use of Exjade from second- to first-line … -
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Human medicine European public assessment report (EPAR): Deferasirox Accord
deferasirox, Iron Overload, beta-Thalassemia
Date of authorisation: 09/01/2020,
, Authorised, Last updated: 04/03/2020
authorised in the EU called Exjade. Expand section Collapse section … with the reference medicine, Exjade, and do not need to be repeated … and to be bioequivalent to Exjade. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Deferasirox Mylan
deferasirox, Iron Overload, beta-Thalassemia
Date of authorisation: 26/09/2019,, Authorised, Last updated: 24/06/2020
authorised in the EU called Exjade. How is Deferasirox Mylan … with the reference medicine, Exjade, and do not need to be repeated … and to be bioequivalent to Exjade. Therefore, the Agency’s … -
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Orphan designation: 4-(3,5-Bis(hydroxy-phenyl)-1,2,4) triazol-1-yl) benzoic acid for: Treatment of chronic iron overload requiring chelation therapy
Date of first decision: 13/03/2002, Expired, Last updated: 30/09/2016triazol-1-yl) benzoic acid (Exjade) has been authorised in the … triazol-1-yl) benzoic acid (Exjade) has been authorised in the … cells). More information on Exjade can be found in the European … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012
CHMP, Last updated: 16/11/2012Exjade … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013
CHMP, Last updated: 26/04/2013Exjade INN deferasirox Marketing-authorisation … indication application for Exjade … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 26-28 June 2006
CHMP, Last updated: 29/06/2006marketing authorisation for Exjade (deferasirox), from Novartis … from Novartis Europharm Ltd. Exjade is indicated for the treatment … Exjade … -
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Human medicine European public assessment report (EPAR): Ferriprox
Deferiprone, beta-Thalassemia, Iron Overload
Date of authorisation: 25/08/1999, Revision: 27, Authorised, Last updated: 20/05/2020 -
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Human medicine European public assessment report (EPAR): Zebinix
eslicarbazepine acetate, Epilepsy
Date of authorisation: 21/04/2009, Revision: 26, Authorised, Last updated: 12/11/2019 -
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Recommendations on medication errors
Last updated: 24/06/2020Exjade: measures to avoid medication …
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PRAC: Agendas, minutes and highlights
Last updated: 14/06/2019 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018
European Medicines Agency, London, UK, from 14/05/2018 to 17/05/2018, Last updated: 14/05/2018 -
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Paediatric Committee (PDCO): 15-17 July 2015
European Medicines Agency, London, UK, from 15/07/2015 to 17/07/2015, Last updated: 17/08/2015 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 November 2015
European Medicines Agency, London, UK, from 16/11/2015 to 19/11/2015, Last updated: 16/11/2015 -
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Committee for Medicinal Products for Human Use (CHMP): 25-28 January 2016
European Medicines Agency, London, UK, from 25/01/2016 to 28/01/2016, Last updated: 25/01/2016 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 November 2015
European Medicines Agency, London, UK, from 03/11/2015 to 06/11/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August-1 September 2017
European Medicines Agency, London, UK, from 29/08/2017 to 01/09/2017, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2014
European Medicines Agency, London, UK, from 10/06/2014 to 13/06/2014, Last updated: 13/08/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2015
European Medicines Agency, London, UK, from 06/07/2015 to 09/07/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 January 2016
European Medicines Agency, London, UK, from 11/01/2016 to 14/01/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2016
European Medicines Agency, London, UK, from 24/10/2016 to 27/10/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 June 2017
European Medicines Agency, London, UK, from 06/06/2017 to 09/06/2017, Last updated: 13/03/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2015
European Medicines Agency, London, UK, from 20/07/2015 to 23/07/2015, Last updated: 03/01/2014 -
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Newsletters (updated)
Last updated: 17/07/2020