31 results
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Opinion/decision on a Paediatric investigation plan (PIP): Afinitor, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000019-PIP06-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 05/05/2014, Last updated: 11/06/2014, Compliance check: XKey facts Afinitor Certican Afinitor and associated names … for everolimus (Afinitor, Certican and associated names) (EMEA-000019-PIP06-09-M05 … for everolimus (Afinitor, Certican and associated names) (EMEA-000019-PIP06-09-M05 … -
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Opinion/decision on a Paediatric investigation plan (PIP): everolimus
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000019-PIP11-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 30/01/2015, Last updated: 05/03/2015, Compliance check: Xspecific waiver for everolimus (Certican and associated names), (EMEA-000019-PIP11-14 … specific waiver for everolimus (Certican and associated names), (EMEA- 000019-PIP11-14 … specific waiver for everolimus (Certican and associated names), (EMEA- 000019-PIP11-14 … -
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National expert: Gerardo Sarno, Italian Medicines Agency (updated)
- Declaration of interests - 80.26 KB | PDF
- Curriculum Vitae - 32.74 KB | PDF
07/2012-09/2014 Novartis Certican (Everolimus) Rejection prophylaxis … -
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National expert: Hans Van Vlierberghe, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 84.39 KB | PDF
- Curriculum Vitae - 68.41 KB | PDF
01/2016-(current) Novartis Certican immune suppression 01/2017-(current … -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,
, Revision: 28, Authorised, Last updated: 21/06/2021
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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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Herbal medicinal product: Mate folium
Ilex paraguariensis St. Hilaire, Maté Leaf, F: Assessment finalised, Last updated: 29/06/2021 -
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National expert: Florian Lasch, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 110.58 KB | PDF
- Curriculum Vitae - 18.07 KB | PDF
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Positive, Last updated: 01/07/2016 -
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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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Paediatric Committee (PDCO): 17-19 July 2013
European Medicines Agency, London, UK, from 17/07/2013 to 19/07/2013, Last updated: 21/12/2010 -
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Paediatric Committee (PDCO): 13-15 August 2014
European Medicines Agency, London, UK, from 13/08/2014 to 15/08/2014, Last updated: 10/12/2010 -
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Paediatric Committee (PDCO): 10-12 September 2014
European Medicines Agency, London, UK, from 10/09/2014 to 12/09/2014, Last updated: 10/12/2010 -
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Public data from Article 57 database
Last updated: 02/06/2021 -
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Paediatric Committee (PDCO): 7-9 August 2013
European Medicines Agency, London, UK, from 07/08/2013 to 09/08/2013, Last updated: 21/12/2010 -
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Annual reports and work programmes
Last updated: 14/06/2021 -
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News: EMA publishes 2013 annual report
Last updated: 30/04/2014 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 05/07/2021 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development
Last updated: 11/06/2021 -
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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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PDCO: meeting archive 2012-2014
Last updated: 03/06/2016 -
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PDCO: Agendas, minutes and meeting reports
Last updated: 11/11/2020 -
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News: Progress in science, medicines, health
Last updated: 30/04/2015