153 results
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Orphan designation: Refusal of orphan designation for the treatment of retinopathy of prematurity
Date of refusal of designation: 28/11/2022, Negative, Last updated: 23/01/2023Sponsor Industria Farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351 … -
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National expert: Alessandra Renieri, European Medicines Agency (updated)
- Declaration of interests - 41.52 KB | PDF
- Curriculum Vitae - 31.68 KB | PDF
Ospedaliera Universitaria Senese • Start date: 1993 • … Ospedaliera Universitaria Senese • Start date: 2002 • … Ospedaliero_Universitaria Senese. 1.11 Committee for Advanced … -
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National expert: Eleftheria Thomaidou, National Organization For Medicines (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 22.21 KB | PDF
Country: Greece 1. Employer: galenica sa • Start date: 091995 • … -
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National expert: Jeanette Birgitta Johansson, Medical Products Agency (updated)
- Declaration of interests - 42.55 KB | PDF
- Curriculum Vitae - 27.43 KB | PDF
related) qQPPV Past 01-01- 2021 01-05- 2022 Galenica AB Cross product related … -
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National expert: Christoph Mueck, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 54.59 KB | PDF
secreted proteins involved in senescence of human endothelial Page … interactions in UVB_induced senescence of human diploid fibroblasts.” … protein 6 delays replicative senescence of human fibroblasts“ Mechanisms … -
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National expert: Pia Rivetti di Val Cervo, Italian Medicines Agency (updated)
- Declaration of interests - 39.33 KB | PDF
- Curriculum Vitae - 33.13 KB | PDF
epidermal differentiation and senescence, as well as brain morphogenesis. • … E.“MicroRNA_191 triggers keratinocytes senescence by SATB1 and CDK6 downregulation.” … feedback in keratinocyte senescence.” Proc Natl Acad Sci USA 109 … -
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National expert: Juan Fernando Martínez Leal, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 40.47 KB | PDF
- Curriculum Vitae - 198.55 KB | PDF
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National expert: Christophe Richez, European Medicines Agency (updated)
- Declaration of interests - 60.86 KB | PDF
- Curriculum Vitae - 29.16 KB | PDF
Barnetche T, Duffau P, Couzi L, Seneschal J, Blanco P, Lazaro E, Richez … Duffau P, Truchetet ME, Seneschal J, Couzi L, Pellegrin JL … Barnetche T, Blanco P, Lazaro E, Seneschal J, Truchetet ME, Duffau P … -
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National expert: Federica Chiara, European Medicines Agency (updated)
- Declaration of interests - 40.45 KB | PDF
- Curriculum Vitae - 206.71 KB | PDF
Molecular mechanisms of Neuronal Senescence. Proteomic, Molecular Oncology … -
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Human medicine European public assessment report (EPAR): Ibrance (updated)
Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,
, Revision: 15, Authorised, Last updated: 22/05/2023
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National expert: Fernando Blanco, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 40.09 KB | PDF
- Curriculum Vitae - 36.39 KB | PDF
al. “Exploring cellular senescence as a tumor suppressor mechanism”.Rev … MV and Romero L. Cellular Senescence and Cancer. Res. Adv. Cancer … -
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Human medicine European public assessment report (EPAR): Akynzeo
netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer
Date of authorisation: 27/05/2015, Revision: 15, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Ameluz
5-aminolevulinic acid hydrochloride, Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 13/12/2011, Revision: 19, Authorised, Last updated: 23/03/2022 -
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Human medicine European public assessment report (EPAR): Spherox
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017, Revision: 8, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Adasuve
loxapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/02/2013, Revision: 14, Authorised, Last updated: 14/11/2022 -
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Human medicine European public assessment report (EPAR): Verzenios
abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018,, Revision: 9, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Jorveza
Budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,
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, Revision: 6, Authorised, Last updated: 06/12/2022
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National expert: Raquel Martin Palomeque, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 190.56 KB | PDF
defence_related genes during senescence: a correlation between gene … -
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Human medicine European public assessment report (EPAR): Skilarence
dimethyl fumarate, Psoriasis
Date of authorisation: 23/06/2017, Revision: 11, Authorised, Last updated: 27/09/2022 -
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Human medicine European public assessment report (EPAR): Cuprior
Trientine tetrahydrochloride, Hepatolenticular Degeneration
Date of authorisation: 05/09/2017, Revision: 6, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Feraccru
ferric maltol, Anemia, Iron-Deficiency
Date of authorisation: 18/02/2016, Revision: 17, Authorised, Last updated: 12/12/2022 -
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Human medicine European public assessment report (EPAR): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 22, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 6, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Pyrukynd
mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Episalvan
Betulae cortex, Wounds and Injuries; Wound Healing
Date of authorisation: 14/01/2016, Revision: 7, Withdrawn, Last updated: 15/07/2022