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Keyword epidyolex Remove keyword
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Orphan designation: Cannabidiol for: Treatment of Lennox-Gastaut syndrome
Date of designation: 20/03/2017, Positive, Last updated: 14/06/2023been authorised in the EU as Epidyolex since 19 September 2019 … Epidyolex Epidyolex cannabidiol Cannabidiol Ca … the orphan designation of Epidyolex at the time of marketing … -
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Orphan designation: Cannabidiol for: Treatment of Dravet syndrome
Date of designation: 15/10/2014, Positive, Last updated: 14/06/2023been authorised in the EU as Epidyolex since 19 September 2019 … Epidyolex Epidyolex cannabidiol Cannabidiol Ca … the orphan designation of Epidyolex at the time of marketing … -
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Orphan designation: Cannabidiol for: Treatment of tuberous sclerosis
Date of designation: 17/01/2018, Positive, Last updated: 15/06/2023been authorised in the EU as Epidyolex since 16 April 2021. Expand … Epidyolex Epidyolex cannabidiol Cannabidiol Ca … -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP01-16-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 08/06/2022, Last updated: 06/10/2021, Compliance check: XInvented name Epidyolex Active substance Cannabidiol … investigation plan for cannabidiol (Epidyolex), (EMEA-001964-PIP01-16-M04 … investigation plan for cannabidiol (Epidyolex), (EMEA-001964-PIP01-16-M04 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 18/03/2020, Last updated: 17/06/2021, Compliance check: XInvented name Epidyolex Active substance Cannabidiol … waiver for cannabidiol (Epidyolex), (EMEA-001964-PIP02-19 … waiver for cannabidiol (Epidyolex), (EMEA-001964-PIP02-19 … -
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Human medicine European public assessment report (EPAR): Epidyolex
Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,
, Revision: 15, Authorised, Last updated: 04/07/2023
Epidyolex Congenital, Hereditary … horised cannabidiol Overview Epidyolex is a medicine used in addition … conditions are rare, and Epidyolex was designated an ‘ A medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cannabidiol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001964-PIP03-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 08/07/2022, Last updated: 19/06/2023, Compliance check: Xa waiver for cannabidiol (Epidyolex), (EMEA-001964-PIP03-21 … waiver for cannabidiol (Epidyolex), (EMEA-001964-PIP03-21 … waiver for cannabidiol (Epidyolex), (EMEA-001964-PIP03-21 … -
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Human medicine European public assessment report (EPAR): Fintepla (updated)
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,
, , Revision: 6, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Hyftor (updated)
Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023,, Revision: 2, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Ztalmy
Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023,, , Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Ontozry
cenobamate, Epilepsy
Date of authorisation: 26/03/2021,, Revision: 5, Authorised, Last updated: 28/06/2023
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Orphan designation: 2-[6-(6,7-Dimethoxyquinolin-3-yl)pyridin-3-yl]-N-[3-(1,1,1-trifluoro-2-methylpropan-2-yl)-1,2-oxazol-5-yl]acetamide (zeteletinib) for: Treatment of medullary thyroid carcinoma (updated)
Date of designation: 19/02/2021, Positive, Last updated: 13/09/2023 -
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Orphan designation: Cedazuridine, decitabine for: Treatment of acute myeloid leukaemia
Date of designation: 10/12/2021, Withdrawn, Last updated: 06/07/2023 -
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Orphan designation: Troriluzole hydrochloride for: Treatment of spinocerebellar ataxia
Date of designation: 10/12/2021, Positive, Last updated: 08/05/2023 -
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Orphan designation: H-Lys-Lys-Gly-Asp-Asn-Ile-Met-Val-Thr-Phe-Arg-Asn-Gln-Ala-Ser-Arg-Pro-Tyr-Gly-Lys-Lys-OH for: Treatment of haemophilia A
Date of designation: 10/08/2022, Positive, Last updated: 09/06/2023 -
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Orphan designation: Dodecyl creatine ester, dodecyl creatine ester hydrochloride for: Treatment of creatine deficiency syndromes
Date of designation: 19/02/2021, Positive, Last updated: 06/02/2023 -
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Orphan designation: Adeno-associated virus vector serotype 9 encoding the human GRN gene for: Treatment of frontotemporal dementia
Date of designation: 10/12/2021, Positive, Last updated: 03/05/2022 -
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Orphan designation: Unesbulin for: Treatment of soft tissue sarcoma
Date of designation: 10/12/2021, Positive, Last updated: 03/05/2022 -
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Orphan designation: Autologous CD34+ cells transduced with a lentiviral RNA vector that results in integrated cDNA encoding for functional cystinosin for: Treatment of cystinosis
Date of designation: 19/02/2021, Positive, Last updated: 18/05/2022 -
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Orphan designation: Autologous CD34+ hematopoietic stem and progenitor cells transfected with zinc finger nuclease mRNAs SB-mRENH1 and SB-mRENH2 for: Treatment of sickle cell disease
Date of designation: 19/02/2021, Positive, Last updated: 25/04/2022 -
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Orphan designation: Tebentafusp for: Treatment of uveal melanoma
Date of designation: 19/02/2021, Positive, Last updated: 22/04/2022 -
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Orphan designation: Garadacimab for: Treatment of hereditary angioedema
Date of designation: 10/12/2021, Positive, Last updated: 13/04/2022 -
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Orphan designation: Macitentan for: Treatment of chronic thromboembolic pulmonary hypertension
Date of designation: 10/12/2021, Positive, Last updated: 13/04/2022 -
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Orphan designation: Allogenic fetal mesenchymal stem cells for: Treatment of osteogenesis imperfecta
Date of designation: 10/12/2021, Positive, Last updated: 05/05/2022 -
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Orphan designation: Autologous T cells ex vivo modified with a lentiviral vector encoding a chimeric antigen receptor specific for CD1a for: Treatment of acute lymphoblastic leukaemia
Date of designation: 10/12/2021, Positive, Last updated: 13/04/2022