86 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: 29/05/2018Update: everolimus (Votubia) has been authorised in the … demonstrated. More information on Votubia can be found in the European … been authorised in the EU as Votubia since 2 September 2011. The … -
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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, 01/06/2018investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … investigation plan for everolimus (Votubia), tablet, dispersible tablet … -
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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, 29/01/2016investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,
, Revision: 25, Authorised, Last updated: 12/02/2020
EMA/229443/2018 EMEA/H/C/002311 Votubia (everolimus) An overview of Votubia and why it is authorised … authorised in the EU What is Votubia and what is it used for … Votubia Tuberous Sclerosis … -
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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) 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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National expert: Klemens Budde, European Medicines Agency (updated)
- Declaration of interests - 87.18 KB | PDF
- Curriculum Vitae - 77.09 KB | PDF
Novartis Sandimmun, Certican, Votubia, Myfortic, Simulect prophylaxis … -
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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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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011
CHMP, Last updated: 24/06/2011review time of 210 days. Votubia (everolimus), an orphan medicine … sclerosis complex. The review of Votubia began on 18 August 2010 with … marketing authorisation for Votubia, which means that further … -
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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 (updated)
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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Human medicine European public assessment report (EPAR): Rapamune
Sirolimus, Graft Rejection, Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 39, Authorised, Last updated: 22/07/2019 -
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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 -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017
European Medicines Agency, London, UK, from 27/11/2017 to 30/11/2017, Last updated: 27/11/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 October 2014
European Medicines Agency, London, UK, from 06/10/2014 to 09/10/2014, Last updated: 13/08/2013 -
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News: European Medicines Agency phasing out follow-up measures
Last updated: 01/08/2012review time of 210 days. Votubia (everolimus), an orphan medicine … sclerosis complex. The review of Votubia began on 18 August 2010 with … marketing authorisation for Votubia, which means that further … -
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Committee for Medicinal Products for Human Use (CHMP): 15-18 May 2017
European Medicines Agency, London, UK, from 15/05/2017 to 18/05/2017, Last updated: 06/01/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2011
European Medicines Agency, London, UK, from 20/06/2011 to 23/06/2011, Last updated: 11/06/2010review time of 210 days. Votubia (everolimus), an orphan medicine … sclerosis complex. The review of Votubia began on 18 August 2010 with … marketing authorisation for Votubia, which means that further … -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2018
European Medicines Agency, London, UK, from 17/09/2018 to 20/09/2018, Last updated: 31/10/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2014
European Medicines Agency, London, UK, from 07/04/2014 to 10/04/2014, Last updated: 13/08/2013