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Orphan designation: everolimus for: Treatment of tuberous sclerosis
Date of designation: 04/08/2010, Positive, Last updated: 29/05/2018everolimus … opinion on orphan designation Everolimus for the treatment of tuberous … Limited, United Kingdom, for everolimus for the treatment of tuberous … -
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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: 27/06/2022everolimus … report Afinitor everolimus Procedure No.: EMEA/H/C/001038/II/0020 … Presentations: Afinitor everolimus See Annex A The following … -
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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
everolimus … EMEA/H/C/002311 Votubia (everolimus) An overview of Votubia … contains the active substance everolimus. Tuberous sclerosis is … -
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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, 01/06/2018Votubia Active substance everolimus Therapeutic area Neurology … paediatric investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … paediatric investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … -
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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: Xassociated names Active substance everolimus Therapeutic area Immunology-Rheumatology-Transplantation … paediatric investigation plan for everolimus (Afinitor, Certican and associated … paediatric investigation plan for everolimus (Afinitor, Certican and … -
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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, 29/01/2016Votubia Active substance everolimus Therapeutic area Neurology … paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001075-PIP04-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/12/2021, Last updated: 16/03/2023, Compliance check: XInvented name Evenity Active substance Romosozumab … investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M04 … investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M04 … -
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Human medicine European public assessment report (EPAR): Evenity
Romosozumab, Osteoporosis
Date of authorisation: 09/12/2019,
, Revision: 3, Authorised, Last updated: 23/02/2023
Evenity Musculoskeletal Diseases Bone … Evenity … THE MEDICINAL PRODUCT EVENITY 105 mg solution for injection … -
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Orphan designation: everolimus for: Treatment of gastric cancer
Date of designation: 30/08/2011, Withdrawn, Last updated: 09/02/2015everolimus … opinion on orphan designation Everolimus for the treatment of gastric … opinion on orphan designation Everolimus for the treatment of gastric … -
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Orphan designation: everolimus for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 14/11/2007, Withdrawn, Last updated: 09/02/2015everolimus … opinion on orphan designation Everolimus for the treatment of gastro-entero-pancreatic … opinion on orphan designation Everolimus for the treatment of gastro-entero-pancreatic … -
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Orphan designation: everolimus for: Treatment of renal-cell carcinoma
Date of designation: 05/06/2007, Withdrawn, Last updated: 06/09/2011everolimus … smop everolimus Rev.3 30 Churchill … opinion on orphan designation Everolimus for the treatment of renal … -
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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: XActive substance everolimus Therapeutic area Oncology … product specific waiver for everolimus (Certican and associated … product specific waiver for everolimus (Certican and associated … -
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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-PIP03-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 15/08/2008, Last updated: 22/08/2014, Compliance check: XActive substance everolimus Therapeutic area Oncology … product specific waiver for everolimus (EMEA-000197-PIP01-08 … product specific waiver for everolimus (EMEA-000197-PIP01-08) in … -
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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-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/12/2007, Last updated: 20/12/2007, Compliance check: XActive substance everolimus Therapeutic area Oncology … Microsoft Word - Decision Everolimus 000019-PIP01-07 European … product specific waiver for Everolimus (EMEA-000019-PIP01-07) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Evenamide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Psychiatry
PIP number: EMEA-002519-PIP03-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 03/12/2021, Last updated: 07/03/2023, Compliance check: XActive substance Evenamide Therapeutic area Psychiatry … granting of a waiver for evenamide (EMEA-002519-PIP03-21) in … granting of a waiver for evenamide (EMEA-002519-PIP03-21) in … -
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Herbal medicinal product: Helichrysi flos (updated)
Helichrysum arenarium (L.) Moench, Sandy everlasting, F: Assessment finalised, Last updated: 02/05/2023the medicinal uses of sandy everlasting. The Committee on Herbal Medicinal … medicines containing sandy everlasting. This summary is not intended … medicines containing sandy everlasting. For practical information … -
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Herbal medicinal product: Oenotherae oleum
Oenothera biennis L.; Oenothera lamarckiana L., Evening primrose oil, F: Assessment finalised, Last updated: 15/09/2021on the medicinal uses of evening primrose oil. The Committee … herbal medicines containing evening primrose oil. This summary … use medicines containing evening primrose oil. For practical … -
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National expert: Evelien Wynendaele, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 39.58 KB | PDF
- Curriculum Vitae - 228.55 KB | PDF
Evelien Wynendaele … Evelien Wynendaele … Vitae Personal information Evelien Wynendaele Work experience … -
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National expert: Everaldo Attard, Medicines Authority (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 55.11 KB | PDF
Everaldo Attard … Everaldo Attard … Vitae Personal information Everaldo Attard Work experience … -
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National expert: Evelina Pusepa, Food And Veterinary Service (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 21.07 KB | PDF
Evelina Pusepa … Evelina Pusepa … Vitae Personal information Evelina Pusepa Work experience … -
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National expert: Evelyn Bach, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 22 KB | PDF
Evelyn Bach … Evelyn Bach … Vitae Personal information Evelyn Bach Work experience … -
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National expert: Evelin Saar, State Agency of Medicines (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 21.1 KB | PDF
Evelin Saar … Evelin Saar … Vitae Personal information Evelin Saar Work experience … -
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National expert: Evelyn Olthof, Medicines Evaluation Board (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 22.02 KB | PDF
Evelyn Olthof … Evelyn Olthof … Vitae Personal information Evelyn Olthof Work experience … -
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National expert: Evert Top, Medicines Evaluation Board (updated)
- Declaration of interests - 39.28 KB | PDF
- Curriculum Vitae - 22.17 KB | PDF
Evert Top … Evert Top … Vitae Personal information Evert Top Work experience … -
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National expert: Evelyne Pirotte, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 23.32 KB | PDF
Evelyne Pirotte … Evelyne Pirotte … Vitae Personal information Evelyne Pirotte Work experience …