107 results
Keyword Gazyvaro Remove keyword
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Orphan designation: Obinutuzumab for: Treatment of chronic lymphocytic leukaemia
Date of designation: 10/10/2012, Positive, Last updated: 21/02/2018been authorised in the EU as Gazyvaro since 23 July 2014. The sponsorship … designation. Update: obinutuzumab (Gazyvaro) has been authorised in the … the EU since 23 July 2014. Gazyvaro in combination with chlorambucil … -
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Orphan designation: Obinutuzumab for: Treatment of follicular lymphoma
Date of designation: 19/06/2015, Positive, Last updated: 21/02/2018been authorised in the EU as Gazyvaro since 13 June 2016. The sponsorship … currently authorised in the EU as Gazyvaro for use in combination with … currently authorised in the EU as Gazyvaro for use in combination with … -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001207-PIP01-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: XInvented name Gazyvaro Active substance Obinutuzumab … investigation plan for obinutuzumab (Gazyvaro), (EMEA-001207-PIP01-11-M01 … investigation plan for obinutuzumab (Gazyvaro), (EMEA-001207-PIP01-11-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: XInvented name Gazyvaro Active substance Obinutuzumab … waiver for obinutuzumab (Gazyvaro), (EMEA-001207-PIP02-19 … waiver for obinutuzumab (Gazyvaro), (EMEA-001207-PIP02-19 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP03-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 17/09/2021, Compliance check: XInvented name Gazyvaro Active substance Obinutuzumab … waiver for obinutuzumab (Gazyvaro), (EMEA-001207-PIP03-20 … waiver for obinutuzumab (Gazyvaro), (EMEA-001207-PIP03-20 … -
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Human medicine European public assessment report (EPAR): Gazyvaro
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,
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, Revision: 14, Authorised, Last updated: 14/12/2022
Gazyvaro Cancer Neoplasms Leukemia … Gazyvaro … 0)88 781 6000 Gazyvaro Procedural steps taken and … -
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Press release: European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia
CHMP, Last updated: 23/05/2014Agency recommends approval of Gazyvaro for chronic lymphocytic leuka … marketing authorisation for Gazyvaro (obinutuzumab) in combination … chronic lymphocytic leukaemia. Gazyvaro has an orphan designation … -
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Press release: New treatment for rare white blood cell cancer
CHMP, Last updated: 29/04/2016follicular lymphoma to be added to Gazyvaro's approved uses … follicular lymphoma to be added to Gazyvaro’s approved uses The European … authorised indication of Gazyvaro (obinutuzumab) to treat patients … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016
CHMP, Last updated: 29/04/2016Gazyvaro. … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2014
CHMP, Last updated: 23/05/2014Gazyvaro … -
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News: European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014
Last updated: 10/07/2014Mekinist (trametinib) and Gazyvaro (obinutuzumab), the anti-inflammatory … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
CHMP, Last updated: 21/07/2017Gazyvaro … -
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National expert: Sandra Lopes, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.63 KB | PDF
Elzonris, Hemlibra, Somavert, Gazyvaro, Groveckly, Padcev, Vyvgart … -
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National expert: Marie-Christine Annequin, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 18.08 KB | PDF
SEQIRUS...), Biotech (UNITUXIN, GAZYVARO, ONCASPAR, REKOVELLE, AIMOVIG … -
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News: Rare Disease Day 2015
Last updated: 26/02/2015of rare cancers, including Gazyvaro, Imbruvica and Zydelig. Targeted … -
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Orphan designation: Obinutuzumab for: Treatment of marginal zone lymphoma
Date of designation: 19/06/2015, Withdrawn, Last updated: 20/10/2016currently authorised in the EU as Gazyvaro for use in combination with … currently authorised in the EU as Gazyvaro for use in combination with … -
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Press release: Record number of medicines for rare diseases recommended for approval in 2014
Last updated: 09/01/2015which Lynparza, Imbruvica, Gazyvaro and Cyramza target rare cancers … which Lynparza, Imbruvica, Gazyvaro and Cyramza target rare cancers … -
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Human medicine European public assessment report (EPAR): Calquence (updated)
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 4, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 11, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Carmustine Obvius
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,
, Revision: 7, Authorised, Last updated: 20/09/2022
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Human medicine European public assessment report (EPAR): Imbruvica
Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014, Revision: 28, Authorised, Last updated: 18/11/2022 -
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Human medicine European public assessment report (EPAR): Copiktra
duvelisib, Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular
Date of authorisation: 19/05/2021,, Revision: 2, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017, Revision: 21, Authorised, Last updated: 07/03/2023 -
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Human medicine European public assessment report (EPAR): Kymriah
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 13, Authorised, Last updated: 07/11/2022
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Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , 
, Authorised, Last updated: 23/06/2022