135 results
Keyword Adcetris Remove keyword
-
List item
Orphan designation: Brentuximab vedotin for: Treatment of cutaneous T-cell lymphoma
Date of designation: 11/01/2012, Positive, Last updated: 26/08/2020been authorised in the EU as Adcetris since 15 December 2017. The … Adcetris Adcetris brentuximab vedotin Brentuximab … the orphan designation of Adcetris at the time of marketing … -
List item
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-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: XInvented name Adcetris Active substance Brentuximab … for brentuximab vedotin (Adcetris), (EMEA-000980-PIP01-10-M07 … for brentuximab vedotin (Adcetris), (EMEA-000980-PIP01-10-M07 … -
List item
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: XInvented name Adcetris Active substance Brentuximab … T-Cell Lymphoma. What is Adcetrix (brentuximab vedotin) and … The active substance in Adcetris, brentuximab vedotin, is made … -
List item
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: XInvented name Adcetris Active substance Brentuximab … Adcetris Adcetris brentuximab vedotin Brentuximab … -
List item
Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,
, 
, Revision: 33, Authorised, Last updated: 21/06/2022
Adcetris Cancer Neoplasms Lymphoma Hemic … brentuximab vedotin Overview Adcetris is a cancer medicine used … non-Hodgkin’s lymphoma, Adcetris is used for: systemic anaplastic … -
List item
Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for: Treatment of peripheral T-cell lymphoma
Date of designation: 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 … marketing authorisation: Adcetris (brentuximab vedotin) for … -
List item
Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for: Treatment of Hodgkin's lymphoma
Date of designation: 15/01/2009, Positive, Last updated: 26/08/2020been authorised in the EU as Adcetris since 25 October 2012. The … Adcetris Adcetris brentuximab vedotin monoclonal … designation EU/3/08/596 for Adcetris (brentuximab vedotin 1 … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
CHMP, Last updated: 27/05/2016Adcetris … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
CHMP, Last updated: 10/11/2017Adcetris … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018
CHMP, Last updated: 14/12/2018Adcetris … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)
CHMP, Last updated: 27/03/2020Adcetris … -
List item
National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 81.57 KB | PDF
- Curriculum Vitae - 48.29 KB | PDF
transplantation" 03/2021-03/2021 Takeda Adcetris webinar entitled "Hodgkin … -
List item
National expert: Paula Boudewina van Hennik, Medicines Evaluation Board (updated)
- Declaration of interests - 79.89 KB | PDF
- Curriculum Vitae - 23.79 KB | PDF
Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012Adcetris … -
List item
National expert: Edward Laane, European Medicines Agency (updated)
- Declaration of interests - 84.03 KB | PDF
- Curriculum Vitae - 24.2 KB | PDF
of Brentuximab Vedotin (Adcetris) for the Treatment of Adult … -
List item
Human medicine European public assessment report (EPAR): Carmustine Obvius
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,
, Revision: 6, Authorised, Last updated: 24/03/2022
-
List item
Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015,, Revision: 46, Authorised, Last updated: 29/06/2022
-
List item
Human medicine European public assessment report (EPAR): Padcev
Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022,, Authorised, Last updated: 18/05/2022
-
List item
National expert: Christian Gisselbrecht, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.94 KB | PDF
- Curriculum Vitae - 39.71 KB | PDF
-
List item
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: 31/05/2022 -
List item
List of medicines under additional monitoring
Last updated: 25/05/2022Limited https://www.ema.europa.eu/en/documents/product-information/adakveo-epar- product-information_en.pdf November 2020 Adcetris Brentuximab vedotin Conditional …
-
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 July 2021
European Medicines Agency, Amsterdam, the Netherlands, from 05/07/2021 to 08/07/2021, Last updated: 10/05/2022 -
List item
PRAC: Agendas, minutes and highlights (updated)
Last updated: 04/07/2022 -
List item
COMP: Agendas, minutes and meeting reports (updated)
Last updated: 28/06/2022 -
List item
CHMP: Agendas, minutes and highlights (updated)
Last updated: 17/06/2022