109 results
Keyword Kaftrio Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Kaftrio, elexacaftor, tezacaftor, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other; Pneumology-allergology
PIP number: EMEA-002324-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XKey facts Kaftrio elexacaftor tezacaftor ivacaftor … tezacaftor / ivacaftor (Kaftrio), (EMEA-002324-PIP01-17-M02 … 13/02/2023 EMA/533018/2021 Generic Kaftrio: EPAR … -
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,
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, Revision: 11, Authorised, Last updated: 16/01/2023
Kaftrio Digestive System Diseases Pancreatic … Kaftrio … acknowledged. EMA/693161/2021 EMEA/H/C/005269 Kaftrio (ivacaftor / tezacaftor … -
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Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor (ivacaftor / tezacaftor / elexacaftor) for: Treatment of cystic fibrosis
Date of designation: 14/12/2018, Positive, Last updated: 25/01/2022been authorised in the EU as Kaftrio since 21 August 2020. The … Kaftrio Kaftrio ivacaftor tezacaftor elexacaftor Ivacaftor … the orphan designation of Kaftrio at the time of marketing … -
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Press release: New medicine for cystic fibrosis patients
CHMP, Last updated: 26/06/2020in the European Union for Kaftrio, the first triple combination … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021
CHMP, Last updated: 26/03/2021Benlysta, Kaftrio, Kalydeco, Saxenda … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020
CHMP, Last updated: 26/06/2020Kaftrio … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
CHMP, Last updated: 12/11/2021Kaftrio … -
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, Revision: 35, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Symkevi
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 11, Authorised, Last updated: 24/03/2023
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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: S-[5-(omega-methoxypoly(oxyethylene)-2-oxopentyl)]-L-cysteinylglycyl-L-serinylglycylgylcyl-L-isoleucyl-L-lysyl-L-glutamyl-L-phenylalanyl-L-leucyl-L-glutaminyl-L-arginyl-L-phenylalanyl-L-isoleucyl-L-histyl-L-isoleucyl-L-valyl-L-glutaminyl-L-serinyl-L-isoleucyl-L-isoleucyl-L-asparaginyl-L-threonyl-L-serinamide, acetate salt for: Treatment of cutaneous T-cell lymphoma
Date of designation: 13/04/2021, Positive, Last updated: 21/01/2022 -
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Orphan designation: Cevostamab for: Treatment of multiple myeloma
Date of designation: 13/04/2021, Positive, Last updated: 24/01/2022 -
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Orphan designation: ganglioside GM1 for: Treatment of amyotrophic lateral sclerosis
Date of designation: 13/04/2021, Positive, Last updated: 24/01/2022 -
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Orphan designation: Refusal of orphan designation for the treatment of non-small cell lung cancer with EGFR alterations
Date of refusal of designation: 28/06/2021, Negative, Last updated: 24/01/2022 -
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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 -
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Orphan designation: Alpelisib for: Treatment of PIK3CA related overgrowth spectrum
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022 -
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Orphan designation: Lorcaserin hydrochloride for: Treatment of Dravet syndrome
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022 -
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Orphan designation: Vatiquinone for: Treatment of Friedreich's ataxia
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023 (updated)
PRAC, Last updated: 22/05/2023 -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023