86 results
Keyword biosimilars Remove keyword
Categories
Human Remove Human filter
Medicine type
Biosimilar Remove Biosimilar filter
-
List item
Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,
, 
, Revision: 1, Authorised, Last updated: 14/09/2021
diabetes. Kirsty is a ‘biosimilar medicine’. This means that … NovoRapid. For more information on biosimilar medicines, see here . Kirsty … aspart. Because Kirsty is a biosimilar medicine, the studies on … -
List item
Human medicine European public assessment report (EPAR): Pelmeg (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 6, Authorised, Last updated: 09/11/2021
leukaemia). Pelmeg is a ‘biosimilar medicine’. This means that … Neulasta. Because Pelmeg is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Pelmeg has a highly … -
List item
Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 6, Authorised, Last updated: 05/11/2021
leukaemia). Cegfila is a ‘biosimilar medicine’. This means that … Neulasta. Because Cegfila is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Cegfila has a … -
List item
Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 4, Authorised, Last updated: 05/11/2021
leukaemia). Nyvepria is a ‘biosimilar medicine’. This means that … Neulasta. Because Nyvepria is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Nyvepria has a … -
List item
Human medicine European public assessment report (EPAR): Fulphila
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 8, Authorised, Last updated: 11/10/2021
leukaemia). Fulphila is a ‘biosimilar medicine’. This means that … medicines. Because Fulphila is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Fulphila has a … -
List item
Human medicine European public assessment report (EPAR): Byooviz (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 1, Authorised, Last updated: 16/11/2021
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … neovascularisation. Byooviz is a ‘biosimilar medicine’. This means that … -
List item
Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 7, Authorised, Last updated: 19/08/2021
leukaemia). Pelgraz is a ‘biosimilar medicine’. This means that … medicines. Because Pelgraz is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Pelgraz has a … -
List item
Human medicine European public assessment report (EPAR): Ziextenzo
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, , Revision: 3, Authorised, Last updated: 12/05/2021
leukaemia). Ziextenzo is a ‘biosimilar medicine’. This means that … medicines. Because Ziextenzo is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Ziextenzo has … -
List item
Human medicine European public assessment report (EPAR): Blitzima
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 11, Authorised, Last updated: 15/09/2021
rituximab. Blitzima is a ‘biosimilar medicine’. This means that … MabThera. For more information on biosimilar medicines, see below. Expand … Rituxan. Because Blitzima is a biosimilar medicine, the studies on … -
List item
Human medicine European public assessment report (EPAR): Rixathon
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, , Revision: 5, Authorised, Last updated: 10/09/2021
rituximab. Rixathon is a ‘biosimilar medicine’. This means that … MabThera. For more information on biosimilar medicines, see here . Expand … Rixathon. Because Rixathon is a biosimilar medicine, the studies on … -
List item
Human medicine European public assessment report (EPAR): Nivestim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010,, Revision: 24, Authorised, Last updated: 24/11/2021
marrow. Nivestim is a ‘biosimilar’ medicine. This means that … information can be found under 'Biosimilar medicines - Overview'. biosimilar medicines , see below. Nivestim … -
List item
Human medicine European public assessment report (EPAR): Grasustek
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 2, Authorised, Last updated: 20/07/2021
leukaemia). Grasustek is a ‘biosimilar medicine’. This means that … medicines. Because Grasustek is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Grasustek has … -
List item
Human medicine European public assessment report (EPAR): Zirabev
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 9, Authorised, Last updated: 27/10/2021
bevacizumab and it is a ‘biosimilar medicine’. This means that … 361). Because Zirabev is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Zirabev has a … -
List item
Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 9, Authorised, Last updated: 26/10/2021
cancers. Trazimera is a ‘biosimilar medicine’. This means that … Herceptin. Because Trazimera is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Trazimera has … -
List item
Human medicine European public assessment report (EPAR): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 5, Authorised, Last updated: 15/10/2021
rituximab. Ruxience is a ‘biosimilar medicine’. This means that … 71%). Because Ruxience is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Ruxience has a … -
List item
Human medicine European public assessment report (EPAR): Hulio
adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018,, , Revision: 9, Authorised, Last updated: 12/10/2021
substance adalimumab and is a ‘biosimilar medicine’. This means that … 358). Because Hulio is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Hulio has a highly … -
List item
Human medicine European public assessment report (EPAR): Riximyo
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,, , Revision: 6, Authorised, Last updated: 21/09/2021
rituximab. Riximyo is a ‘biosimilar medicine’. This means that … MabThera. For more information on biosimilar medicines, see below. Expand … patients). Because Riximyo is a biosimilar medicine, the studies on … -
List item
Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 8, Authorised, Last updated: 13/09/2021
cancers. Kanjinti is a ‘biosimilar medicine’. This means that … indications. Because Kanjinti is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Kanjinti has been … -
List item
Human medicine European public assessment report (EPAR): Mvasi
bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, , Revision: 11, Authorised, Last updated: 06/09/2021
medicines. Mvasi is a ‘biosimilar medicine’. This means that … 314). Because Mvasi is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Mvasi has a highly … -
List item
Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 1, Authorised, Last updated: 11/08/2021
medicines work. Alymsys is a ‘biosimilar medicine’. This means that … comparable. Because Alymsys is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Alymsys has a … -
List item
Human medicine European public assessment report (EPAR): Movymia (updated)
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, Revision: 9, Authorised, Last updated: 03/11/2021
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … teriparatide. Movymia is a ‘biosimilar medicine’. This means that … -
List item
Human medicine European public assessment report (EPAR): Grastofil
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,, Revision: 13, Authorised, Last updated: 16/10/2020
appropriate. Grastofil is a ‘biosimilar medicine’. This means that … with EU requirements for biosimilar medicines, Grastofil has … -
List item
Human medicine European public assessment report (EPAR): Erelzi
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, , Revision: 9, Authorised, Last updated: 10/06/2021
substance etanercept and is a ‘biosimilar medicine’. This means that … activity. Because Erelzi is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Erelzi has a highly … -
List item
Human medicine European public assessment report (EPAR): Hyrimoz (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, , Revision: 9, Authorised, Last updated: 19/11/2021
substance adalimumab and is a ‘biosimilar medicine’. This means that … Humira. For more information on biosimilar medicines, see here . Expand … Humira. Because Hyrimoz is a biosimilar medicine, the studies on … -
List item
Human medicine European public assessment report (EPAR): Zercepac
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 5, Authorised, Last updated: 19/08/2021
cancers. Zercepac is a ‘biosimilar medicine’. This means that … Herceptin). Because Zercepac is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Zercepac has a …