105 results
Keyword Jakavi Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000901-PIP04-17-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: XInvented name Jakavi Active substance Ruxolitinib … ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP04-17-M02 … ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP04-17-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000901-PIP03-16-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Tablet, Age-appropriate dosage form
Decision date: 09/04/2021, Last updated: 18/01/2022, Compliance check: XInvented name Jakavi Active substance Ruxolitinib … ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP03-16-M02 … ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP03-16-M02 … -
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Human medicine European public assessment report (EPAR): Jakavi
ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Date of authorisation: 23/08/2012, Revision: 28, Authorised, Last updated: 31/07/2023Jakavi Bone Marrow Neoplasms Hematologic … horised ruxolitinib Overview Jakavi is a medicine used to treat … did not work well enough. Jakavi contains the The substance … -
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Orphan designation: (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate for: Treatment of chronic idiopathic myelofibrosis
Date of designation: 07/11/2008, Withdrawn, Last updated: 08/05/2015been authorised in the EU as Jakavi since 23 August 2012. Expand … R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate (Jakavi) has been authorised in the … 3/5 More information on Jakavi can be found in the European … -
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Orphan designation: (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate for: Treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
Date of designation: 03/04/2009, Withdrawn, Last updated: 08/05/2015been authorised in the EU as Jakavi since 23 August 2012. Expand … R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate (Jakavi) was authorised in the EU … of marketing authorisation Jakavi (ruxolitinib) for the treatment … -
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Orphan designation: Ruxolitinib for: Treatment of polycythaemia vera
Date of designation: 19/02/2014, Withdrawn, Last updated: 08/05/2015authorised under the name of Jakavi for the treatment of myelofibrosis … authorised under the name of Jakavi for the treatment of myelofibrosis … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015
CHMP, Last updated: 23/01/2015Jakavi … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
CHMP, Last updated: 25/03/2022Jakavi … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012
CHMP, Last updated: 20/04/2012PDF icon application/pdf Jakavi ruxolitinib Novartis Europharm … -
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News: EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
PRAC, Last updated: 11/02/2022disorders. Some JAK inhibitors (Jakavi and Inrebic) are used to … -
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Human medicine European public assessment report (EPAR): Opzelura
ruxolitinib phosphate, Vitiligo
Date of authorisation: 19/04/2023, Revision: 1, Authorised, Last updated: 22/06/2023 -
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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: 03/11/2022disorders. Some JAK inhibitors (Jakavi and Inrebic) are used to … -
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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
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Human medicine European public assessment report (EPAR): Reblozyl
Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020,, , Revision: 5, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Olumiant (updated)
Baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,
, Revision: 16, Authorised, Last updated: 21/09/2023
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Human medicine European public assessment report (EPAR): Cibinqo
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,, , Revision: 5, Authorised, Last updated: 30/06/2023
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Human medicine European public assessment report (EPAR): Rinvoq
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, , Revision: 17, Authorised, Last updated: 29/08/2023
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,, Revision: 27, Authorised, Last updated: 12/06/2023
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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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Withdrawn application: Enpaxiq
date of withdrawal: 20/02/2017, Initial authorisation, Last updated: 09/06/2017 -
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Referral: Janus kinase inhibitors (JAKi)
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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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 September 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 25/09/2023 to 28/09/2023, Last updated: 25/09/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023 (updated)
PRAC, Last updated: 29/09/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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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