38 results
Keyword Inrebic Remove keyword
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Human medicine European public assessment report (EPAR): Inrebic
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,
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, Revision: 4, Authorised, Last updated: 21/03/2023
Inrebic Cancer Bone Marrow Diseases Hematologic … Inrebic … EMA/694589/2020 EMEA/H/C/005026 Inrebic (fedratinib) An overview of Inrebic and why it is authorised … -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-polycythaemia vera myelofibrosis
Date of designation: 26/11/2010, Positive, Last updated: 17/09/2021been authorised in the EU as Inrebic since 8 February 2021. … Inrebic Inrebic fedratinib N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino … the orphan designation of Inrebic at the time of marketing … -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of designation: 26/11/2010, Positive, Last updated: 17/09/2021been authorised in the EU as Inrebic since 8 February 2021. … Inrebic Inrebic fedratinib N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino … the orphan designation of Inrebic at the time of marketing … -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of primary myelofibrosis
Date of designation: 01/10/2010, Positive, Last updated: 17/09/2021been authorised in the EU as Inrebic since 8 February 2021. … Inrebic Inrebic fedratinib N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino … the orphan designation of Inrebic at the time of marketing … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020Inrebic … -
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News: EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
PRAC, Last updated: 11/02/2022JAK inhibitors (Jakavi and Inrebic) are used to treat myeloproliferative … -
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News: EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
PRAC, Last updated: 03/11/2022JAK inhibitors (Jakavi and Inrebic) are used to treat myeloproliferative … -
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News: EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
CHMP, Last updated: 13/01/2023 -
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Referral: Janus kinase inhibitors (JAKi) (updated)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/05/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 30/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/03/2022 to 10/03/2022, Last updated: 22/11/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 24/04/2023 -
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Newsletters (updated)
Last updated: 30/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2023
European Medicines Agency, Amsterdam, the Netherlands, from 23/01/2023 to 26/01/2023, Last updated: 14/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 26/09/2022 to 29/09/2022, Last updated: 04/07/2022 -
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Committee for Orphan Medicinal Products (COMP): 1-3 December 2020
Virtual meeting, from 01/12/2020 to 03/12/2020, Last updated: 06/06/2017 -
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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 09/06/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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Committee for Orphan Medicinal Products (COMP): 19-21 January 2021
European Medicines Agency, Amsterdam, the Netherlands, from 19/01/2021 to 21/01/2021, Last updated: 03/02/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 12/08/2022 -
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Parallel distribution: Regulatory and procedural guidance
Last updated: 09/06/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 20/06/2022 to 23/06/2022, Last updated: 18/08/2022 -
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Download medicine data
Last updated: 02/12/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
PRAC, Last updated: 30/09/2022