114 results
Keyword Adcetris Remove keyword
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Orphan designation: Brentuximab vedotin for: Treatment of cutaneous T-cell lymphoma
Date of first decision: 11/01/2012, Positive, Last updated: 26/08/2020been authorised in the EU as Adcetris since 15 December 2017. The … the orphan designation of Adcetris at the time of marketing … organisations registered in Europe. Adcetris: EPAR … -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 22/06/2020, Last updated: 17/03/2021, Compliance check: XKey facts Adcetris Brentuximab vedotin OncologyP/0243/2020EMEA-000980-PIP01-10-M06 … for brentuximab vedotin (Adcetris) (EMEA-000980-PIP01-10-M06 … 17/03/2021 EMA/324798/2020 Generic Adcetris: EPAR … -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 07/08/2015, Last updated: 17/12/2015, Compliance check: XKey facts Adcetris Brentuximab vedotin OncologyP/0168/2015EMEA-000980-PIP02-15 … for brentuximab vedotin (Adcetris), (EMEA-000980-PIP02-15 … 22/09/2015 EMA/473694/2015 Generic Adcetris: EPAR … -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/10/2018, Last updated: 11/01/2019, Compliance check: XKey facts Adcetris Brentuximab vedotin OncologyP/0327/2018EMEA-000980-PIP04-18 … for brentuximab vedotin (Adcetris), (EMEA-000980-PIP04-18 … 11/01/2019 EMA/646757/2018 Generic Adcetris: EPAR … -
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Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,
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, Revision: 28, Authorised, Last updated: 18/12/2020
Adcetris Lymphoma, Non-Hodgkin Hodgkin … Adcetris … Adcetris, INN-brentuximab vedotin … -
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Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for: Adjunctive treatment in haematopoietic cell transplantation
Date of first decision: 15/01/2009, Positive, Last updated: 26/08/2020been authorised in the EU as Adcetris since 25 October 2012. The … designation EU/3/08/596 for Adcetris (brentuximab vedotin 1 … the orphan designation of Adcetris at the time of change to … -
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Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for: Treatment of peripheral T-cell lymphoma
Date of first decision: 21/09/2019, Positive, Last updated: 26/08/2020been authorised in the EU as Adcetris since 30 October 2012. The … was authorised in the EU as Adcetris for the treatment of Hodgkin’s … the orphan designation of Adcetris at the time of change to … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
CHMP, Last updated: 27/05/2016Adcetris … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
CHMP, Last updated: 10/11/2017Adcetris … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018
CHMP, Last updated: 14/12/2018Adcetris … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)
CHMP, Last updated: 27/03/2020Adcetris … -
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National expert: Edward Laane, European Medicines Agency (updated)
- Declaration of interests - 83.95 KB | PDF
- Curriculum Vitae - 23.59 KB | PDF
Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult … -
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National expert: Paula Boudewina van Hennik, Medicines Evaluation Board (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 23.29 KB | PDF
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012Adcetris … -
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 33, Authorised, Last updated: 29/04/2021
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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: 5, Authorised, Last updated: 21/10/2020
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National expert: Christian Gisselbrecht, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.91 KB | PDF
- Curriculum Vitae - 34.18 KB | PDF
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2021 to 22/04/2021, Last updated: 19/04/2021 -
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PRAC: Agendas, minutes and highlights
Last updated: 16/02/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/2020 -
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List of medicines under additional monitoring
Last updated: 31/03/2021available November 2020 Adcetris Brentuximab vedotin Conditional …
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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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COMP: Agendas, minutes and meeting reports
Last updated: 03/02/2021 -
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Scientific publications
Last updated: 04/02/2021