108 results
Keyword Votubia Remove keyword
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Orphan designation: everolimus for: Treatment of tuberous sclerosis
Date of designation: 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 … Update: everolimus (Votubia) has been authorised in 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, 01/06/2018Invented name Votubia Active substance everolimus … investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … -
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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, 29/01/2016Invented name Votubia Active substance everolimus … 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: 30, Authorised, Last updated: 27/06/2022
Votubia Cancer Neoplasms Hamartoma Neoplastic … Votubia … EMA/229443/2018 EMEA/H/C/002311 Votubia (everolimus) An overview of Votubia and why it is authorised … -
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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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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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National expert: Hugues Malonne, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 41.96 KB | PDF
- Curriculum Vitae - 46.87 KB | PDF
lun null Past 01-02- 2015 01-05- 2015 Novartis Individual product related Votubia Tuberous sclerosis null 1.3 … -
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Orphan designation: Sirolimus for: Treatment of tuberous sclerosis
Date of designation: 20/06/2017, Positive, Last updated: 19/07/2022designation, 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 designation: 23/08/2017, Positive, Last updated: 30/11/2021designation, the medicine Votubia (everolimus) was authorised … designation, the medicine Votubia (everolimus) was authorised … -
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Orphan designation: Cannabidiol for: Treatment of tuberous sclerosis
Date of designation: 17/01/2018, Positive, Last updated: 26/04/2021designation, 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 designation: 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): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 14, Authorised, Last updated: 25/05/2023
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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: 30, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Rapamune
Sirolimus, Graft Rejection; Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 46, Authorised, Last updated: 25/07/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 24/04/2023 to 26/04/2023, Last updated: 24/04/2023 -
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PRAC recommendations on safety signals (updated)
Last updated: 08/05/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 31/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/03/2022 to 10/03/2022, Last updated: 22/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021, Last updated: 04/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/05/2021 to 20/05/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/03/2021 to 25/03/2021, Last updated: 07/12/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023