105 results
Keyword Tasigna Remove keyword
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Withdrawn application: Tasigna
nilotinib, date of withdrawal: 21/05/2014, Post-authorisation, Last updated: 27/06/2014Tasigna: Withdrawn application … marketing authorisation for Tasigna (nilotinib) On 21 May … for a new indication for Tasigna to treat patients with … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tasigna, nilotinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000290-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 21/12/2015, Last updated: 21/12/2016, Compliance check: V, 11/11/2016Invented name Tasigna Active substance nilotinib … investigation plan for nilotinib (Tasigna) (EMEA-000290-PIP01-08-M04 … investigation plan for nilotinib (Tasigna) (EMEA-000290-PIP01-08-M04 … -
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Human medicine European public assessment report (EPAR): Tasigna (updated)
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 45, Authorised, Last updated: 27/11/2023Tasigna Cancer Neoplasms Leukemia … Authorised nilotinib Overview Tasigna is a medicine for treating … or do not work for them. Tasigna is only for patients with … -
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Orphan designation: nilotinib for: Treatment of chronic myeloid leukaemia
Date of designation: 22/05/2006, Expired, Last updated: 20/01/2020been authorised in the EU as Tasigna since 19 November 2007. The … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014
Last updated: 27/06/2014Tasigna … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017
CHMP, Last updated: 15/09/2017Tasigna … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23 September 2010
CHMP, Last updated: 24/09/2010Tasigna … -
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Human medicine European public assessment report (EPAR): Sprycel
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 20/11/2006, Revision: 41, Authorised, Last updated: 30/10/2023 -
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Human medicine European public assessment report (EPAR): Bosulif
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013, Revision: 24, Authorised, Last updated: 17/05/2023 -
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Human medicine European public assessment report (EPAR): Imatinib Teva
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,
, Revision: 19, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Spectrila (updated)
asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 6, Authorised, Last updated: 20/11/2023 -
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Human medicine European public assessment report (EPAR): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 17/04/2013,, Revision: 13, Withdrawn, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 20, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,
, Revision: 46, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Iclusig
Ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,
, Revision: 24, Authorised, Last updated: 21/10/2022
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Human medicine European public assessment report (EPAR): Oncaspar
pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 16, Authorised, Last updated: 25/01/2023 -
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National expert: Paolo Antonio Ascierto, European Medicines Agency (updated)
- Declaration of interests - 55.66 KB | PDF
- Curriculum Vitae - 153.5 KB | PDF
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Sampling and testing (updated)
Last updated: 07/11/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 27/11/2023 -
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PRAC recommendations on safety signals (updated)
Last updated: 20/11/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 10/11/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/03/2021 to 25/03/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/05/2021 to 20/05/2021, Last updated: 07/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
Virtual meeting, from 31/08/2020 to 03/09/2020, Last updated: 27/02/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 September 2015
European Medicines Agency, London, UK, from 07/09/2015 to 10/09/2015, Last updated: 13/03/2014