95 results
Keyword votubia Remove keyword
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Orphan designation: everolimus for: Treatment of tuberous sclerosis
Date of first decision: 04/08/2010, Positive, Last updated: 29/05/2018been authorised in the EU as Votubia since 2 September 2011. The … designation. Update: Everolimus (Votubia) was authorised in the EU … designation EU/3/10/764 for Votubia (everolimus) as an orphan … -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP08-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: V, 01/06/2018Key facts Votubia everolimus NeurologyP/0316/2017EMEA-000019-PIP08-12-M03 … investigation plan for everolimus (Votubia) (EMEA-000019-PIP08-12-M03 … 13/02/2018 EMA/666624/2017 Generic Votubia: EPAR … -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016Key facts Votubia everolimus NeurologyP/0003/2014EMEA-000019-PIP02-07-M05 … investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … 19/02/2014 EMA/776286/2013 Generic Votubia: EPAR … -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,
, Revision: 27, Authorised, Last updated: 16/09/2020
Votubia Tuberous Sclerosis … thorised everolimus Overview Votubia is a medicine used to treat … responded to other treatments. Votubia is used for partial-onset … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Cimzia, Kineret, Votubia … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012
CHMP, Last updated: 21/09/2012Votubia … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
CHMP, Last updated: 16/12/2016Votubia … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020Votubia INN everolimus Marketing-authorisation … and answers on the use of Votubia in children from 6 months … -
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National expert: Hugues Malonne, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.12 KB | PDF
- Curriculum Vitae - 34.11 KB | PDF
02/2015-05/2015 Novartis Votubia Tuberous sclerosis 11/2015-12/2015 … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011
CHMP, Last updated: 24/06/2011Votubia … review time of 210 days. Votubia (everolimus), an orphan medicine … sclerosis complex. The review of Votubia began on 18 August 2010 with … -
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Human medicine European public assessment report (EPAR): Rapamune (updated)
Sirolimus, Graft Rejection, Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 41, Authorised, Last updated: 12/03/2021 -
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Orphan designation: Cannabidiol for: Treatment of tuberous sclerosis
Date of first decision: 17/01/2018, Positive, Last updated: 23/04/2019designation, the medicine Votubia (everolimus) was authorised … designation, the medicine Votubia (everolimus) was authorised … -
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Orphan designation: Sirolimus for: Treatment of tuberous sclerosis
Date of first decision: 23/08/2017, Positive, Last updated: 08/04/2019designation, the medicine Votubia (everolimus) was authorised … designation, the medicine Votubia (everolimus) was authorised … -
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Orphan designation: Sirolimus for: Treatment of tuberous sclerosis
Date of first decision: 20/06/2017, Positive, Last updated: 17/07/2017designation, the medicine Votubia (everolimus) was authorised … designation, the medicine Votubia (everolimus) was authorised … -
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Orphan designation: Sirolimus for: Treatment of tuberous sclerosis
Date of first decision: 09/10/2015, Positive, Last updated: 18/11/2015designation, the medicine Votubia (everolimus) was authorised … designation, the medicine Votubia (everolimus) was authorised … -
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Human medicine European public assessment report (EPAR): Afinitor
everolimus, Carcinoma, Renal Cell, Breast Neoplasms, Pancreatic Neoplasms
Date of authorisation: 02/08/2009, Revision: 25, Authorised, Last updated: 06/07/2020 -
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Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 10/03/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 9-12 November 2020
Virtual meeting, from 09/11/2020 to 12/11/2020, Last updated: 07/01/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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CHMP: Agendas, minutes and highlights
Last updated: 29/01/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 October 2020
Virtual meeting, from 26/10/2020 to 29/10/2020, Last updated: 08/01/2021 -
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PRAC: Agendas, minutes and highlights
Last updated: 16/02/2021 -
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Paediatric Committee (PDCO): 1-4 September 2020
Virtual meeting, from 01/09/2020 to 04/09/2020, Last updated: 16/10/2020 -
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Paediatric Committee (PDCO): 12-14 August 2015
European Medicines Agency, London, UK, from 12/08/2015 to 14/08/2015, Last updated: 19/02/2013 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 March 2018
European Medicines Agency, London, UK, from 19/03/2018 to 22/03/2018, Last updated: 31/05/2018