102 results
Keyword Kyprolis Remove keyword
-
List item
Orphan designation: carfilzomib for: Treatment of multiple myeloma
Date of designation: 03/06/2008, Positive, Last updated: 02/12/2015Carfilzomib (Kyprolis) has been authorised in the … EU since 19 November 2015. Kyprolis in combination with lenalidomide … Kyprolis Kyprolis carfilzomib carfilzomib ca … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001806-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: XInvented name Kyprolis Active substance carfilzomib … waiver for carfilzomib (Kyprolis), (EMEA-001806-PIP04-19 … waiver for carfilzomib (Kyprolis), (EMEA-001806-PIP04-19 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001806-PIP03-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 15/05/2019, Last updated: 29/10/2019, Compliance check: XInvented name Kyprolis Active substance carfilzomib … Kyprolis Kyprolis carfilzomib carfilzomib ca … -
List item
Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,
, 
, Revision: 20, Authorised, Last updated: 15/06/2022
Kyprolis Cancer Neoplasms Neoplasms … horised carfilzomib Overview Kyprolis is a cancer medicine used … treatment for their cancer. Kyprolis contains the The substance … -
List item
Press release: New treatment option for patients with rare blood cancer
CHMP, Last updated: 25/09/2015Kyprolis recommended under accelerated … patients with rare blood cancer Kyprolis recommended under accelerated … marketing authorisation for Kyprolis (carfilzomib) to treat patients … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2020
CHMP, Last updated: 13/11/2020Kyprolis … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015
CHMP, Last updated: 25/09/2015Kyprolis … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
CHMP, Last updated: 27/05/2016Kyprolis … -
List item
News: Clinical data for two more medicines now available online
Last updated: 24/11/2016to the clinical data for Kyprolis and Zurampic, published on … -
List item
Press release: Opening up clinical data on new medicines
Last updated: 20/10/2016data is published today are Kyprolis (carfilzomib), an orphan … data is published today are Kyprolis (carfilzomib), an orphan … -
List item
Human medicine European public assessment report (EPAR): Sarclisa
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,
, Revision: 7, Authorised, Last updated: 25/04/2023
-
List item
Human medicine European public assessment report (EPAR): Zolsketil pegylated liposomal
doxorubicin hydrochloride, liposomal, Ovarian Neoplasms; Sarcoma, Kaposi; Multiple Myeloma
Date of authorisation: 31/05/2022, Revision: 1, Authorised, Last updated: 04/05/2023 -
List item
Human medicine European public assessment report (EPAR): Neofordex (updated)
dexamethasone, Multiple Myeloma
Date of authorisation: 16/03/2016, Revision: 11, Authorised, Last updated: 17/05/2023 -
List item
Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , Revision: 20, Authorised, Last updated: 22/03/2023
-
List item
Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, Revision: 12, Authorised, Last updated: 01/06/2023
-
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , 
, Revision: 5, Authorised, Last updated: 31/03/2023
-
List item
Human medicine European public assessment report (EPAR): Celdoxome pegylated liposomal
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms; Multiple Myeloma; Sarcoma, Kaposi
Date of authorisation: 15/09/2022, Revision: 1, Authorised, Last updated: 13/04/2023 -
List item
Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 3, Authorised, Last updated: 14/04/2023
-
List item
Human medicine European public assessment report (EPAR): Nexpovio
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, Revision: 7, Authorised, Last updated: 20/02/2023
-
List item
Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,, , Authorised, Last updated: 07/03/2023
-
List item
Human medicine European public assessment report (EPAR): Pepaxti
Melphalan flufenamide hydrochloride, Multiple Myeloma
Date of authorisation: 17/08/2022, Revision: 1, Authorised, Last updated: 19/12/2022 -
List item
Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,, , , Revision: 5, Authorised, Last updated: 21/12/2022
-
List item
Human medicine European public assessment report (EPAR): Thalidomide Lipomed
Thalidomide, Multiple Myeloma
Date of authorisation: 19/09/2022, Authorised, Last updated: 20/10/2022 -
List item
Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 15, Authorised, Last updated: 01/02/2023
-
List item
Human medicine European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021,
, Revision: 3, Authorised, Last updated: 22/12/2021