90 results
Keyword alpelisib Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002016-PIP03-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 03/12/2021, Last updated: 22/03/2023, Compliance check: Xname Piqray Active substance Alpelisib Therapeutic area Other Decision … paediatric investigation plan for alpelisib (Piqray and associated names … paediatric investigation plan for alpelisib (Piqray and associated names … -
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Human medicine European public assessment report (EPAR): Piqray
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,
, Revision: 8, Authorised, Last updated: 20/02/2023
Authorised alpelisib Overview Piqray is a cancer … medicine. active substance alpelisib. How is Piqray used? Piqray … active substance in Piqray, alpelisib, works by blocking the activity … -
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Opinion/decision on a Paediatric investigation plan (PIP): Piqray, Alpelisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002016-PIP04-20, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 17/03/2021, Last updated: 05/11/2021, Compliance check: V, 20/09/2019name Piqray Active substance Alpelisib Therapeutic area Oncology … product specific waiver for alpelisib (Piqray), (EMEA-002016-PIP04-20 … product specific waiver for alpelisib (Piqray), (EMEA-002016-PIP04-20 … -
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Orphan designation: Alpelisib for: Treatment of PIK3CA related overgrowth spectrum
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022Alpelisib Overview This medicine was … of the affected tissues. Alpelisib is a PI3K inhibitor and is … multiplication of the cells. Alpelisib is expected to both reduce … -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpelisib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002016-PIP02-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2017, Last updated: 21/04/2017, Compliance check: XKey facts Alpelisib OncologyP/0079/2017EMEA-002016-PIP02-16 … product specific waiver for alpelisib (EMEA-002016-PIP02-16) PDF … product specific waiver for alpelisib (EMEA-002016-PIP02-16) in … -
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National expert: Kevin Punie, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 87.31 KB | PDF
- Curriculum Vitae - 37.86 KB | PDF
06/2019-(current) Novartis Alpelisib Breast Cancer Punie 2022-06-07 3 Classified … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020alpelisib) received a positive opinion … -
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National expert: Malin Johansen, Norwegian Medicines Agency (updated)
- Declaration of interests - 80.82 KB | PDF
- Curriculum Vitae - 17.07 KB | PDF
Novartis (CTL019, PDR001 and alpelisib in variuos types of cancer … -
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National expert: Theodoros Foukakis, European Medicines Agency (updated)
- Declaration of interests - 82.89 KB | PDF
- Curriculum Vitae - 20.35 KB | PDF
12/2020-12/2020 Novartis Alpelisib Breast cancer 2.4 Financial … -
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National expert: Antonio Gonzalez-Martin, European Medicines Agency (updated)
- Declaration of interests - 84.22 KB | PDF
- Curriculum Vitae - 18.06 KB | PDF
01/2019-(current) NOVARTIS ALPELISIB PLATIUM RESISTANT OVARIAN … -
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National expert: Philipp Harter, European Medicines Agency (updated)
- Declaration of interests - 84.81 KB | PDF
- Curriculum Vitae - 17.39 KB | PDF
07/2022-07/2022 Novartis Alpelisib Ovarian cancer 08/2021-12/2021 … -
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National expert: Alexandra Leary, European Medicines Agency (updated)
- Declaration of interests - 85.56 KB | PDF
- Curriculum Vitae - 17.33 KB | PDF
cancer 08/2022-(current) AZ Alpelisib ovarian cancer 06/2019-(current … -
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National expert: Francesca Rocchi, Italian Medicines Agency (updated)
- Declaration of interests - 81.55 KB | PDF
- Curriculum Vitae - 27.96 KB | PDF
sought for the treatment with alpelisib of five patients harboring … -
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National expert: Ignace Vergote, European Medicines Agency (updated)
- Declaration of interests - 85.01 KB | PDF
- Curriculum Vitae - 16.73 KB | PDF
01/2021-(current) Novartis alpelisib ovarian cancer 01/2020-(current … -
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, 
, Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Keytruda
pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015, Revision: 49, Authorised, Last updated: 06/12/2022 -
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Withdrawn application: Febseltiq
infigratinib, date of withdrawal: 11/10/2022, Initial authorisation, Last updated: 30/01/2023 -
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Withdrawn application: Parsaclisib Incyte Biosciences Distribution B.V.
parsaclisib, date of withdrawal: 27/06/2022, Initial authorisation, Last updated: 08/11/2022 -
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Orphan designation: Herpes simplex virus 1 expressing the human CFTR gene for: Treatment of cystic fibrosis
Date of designation: 26/03/2021, Positive, Last updated: 17/01/2023 -
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Orphan designation: Ilixadencel for: Treatment of gastrointestinal stromal tumours
Date of designation: 26/03/2021, Positive, Last updated: 28/09/2022 -
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Orphan designation: Lefitolimod for: Treatment of small cell lung cancer
Date of designation: 26/03/2021, Positive, Last updated: 19/05/2022 -
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Orphan designation: 5-fluoro-4-(7'-fluoro-2'-methylspiro[cyclopentane-1,3'-indol]-5'-yl)-N-(5-(1-methylpiperidin-4-yl)pyridin-2-yl)pyrimidin-2-amine for: Treatment of glioma
Date of designation: 26/03/2021, Positive, Last updated: 25/02/2022 -
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Orphan designation: Alpha-L-iduronidase fused to Fab fragment of a humanised monoclonal antibody targeting human transferrin receptor for: Treatment of mucopolysaccharidosis type I
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022 -
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Orphan designation: Adeno-associated virus serotype hu68 containing the human GALC gene for: Treatment of Krabbe disease
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022 -
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Orphan designation: Messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene for: Treatment of ATTR amyloidosis
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022