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Human medicine European public assessment report (EPAR): Ziextenzo
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,
, 
, Revision: 4, Authorised, Last updated: 03/02/2022
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 … -
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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 … -
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Human medicine European public assessment report (EPAR): Semglee
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 6, Authorised, Last updated: 14/01/2022
glargine. Semglee is a ‘biosimilar medicine’. This means that … glucose. Because Semglee is a biosimilar medicine, studies on effectiveness … with EU requirements for biosimilar medicines, Semglee has been … -
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,, , Revision: 7, Authorised, Last updated: 07/04/2022
Insulin lispro Sanofi is a ‘biosimilar medicine’. This means that … with EU requirements for biosimilar medicines, Insulin lispro … Insulin lispro Sanofi is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, , Revision: 9, Authorised, Last updated: 23/05/2022
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … -
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Human medicine European public assessment report (EPAR): Blitzima
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 14, Authorised, Last updated: 12/04/2022
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 … -
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
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 … -
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Human medicine European public assessment report (EPAR): Nyvepria
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 … -
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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: 7, Authorised, Last updated: 21/03/2022
rituximab. Ruxience is a ‘biosimilar medicine’. This means that … MabThera. For more information on biosimilar medicines, see here . Expand … 71%). Because Ruxience is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,, Revision: 3, Authorised, Last updated: 27/01/2022
Insulin aspart Sanofi is a ‘biosimilar medicine’. This means that … Insulin aspart Sanofi is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Insulin aspart … -
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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 … -
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Human medicine European public assessment report (EPAR): Grastofil
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,, Revision: 14, Authorised, Last updated: 10/01/2022
appropriate. Grastofil is a ‘biosimilar medicine’. This means that … with EU requirements for biosimilar medicines, Grastofil has … -
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Human medicine European public assessment report (EPAR): Truxima
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017,, Revision: 16, Authorised, Last updated: 12/04/2022
rituximab. Truxima is a ‘biosimilar medicine’. This means that … activity. Because Truxima is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Truxima has a … -
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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: 10, Authorised, Last updated: 29/03/2022
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 … -
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Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 2, Authorised, Last updated: 11/04/2022
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 … -
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Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 10, Authorised, Last updated: 28/01/2022
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 … -
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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 … -
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 9, Authorised, Last updated: 21/01/2022
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 … -
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Human medicine European public assessment report (EPAR): Lusduna
insulin glargine, Diabetes Mellitus
Date of authorisation: 03/01/2017,, Revision: 2, Withdrawn, Last updated: 22/01/2019
chemical (ATC) code A10AE04 Biosimilar Biosimilar Biosimilar This is a biosimilar medicine, which is a biological … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, , Revision: 3, Withdrawn, Last updated: 25/11/2021
under additional monitoring . Biosimilar Biosimilar Biosimilar This is a biosimilar medicine, which is a biological … work. Equidacent is a ‘biosimilar medicine’. This means that … Avastin. For more information on biosimilar medicines, see here. Equidacent … -
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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: 2, Authorised, Last updated: 21/12/2021
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 … -
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Human medicine European public assessment report (EPAR): Stimufend
pegfilgrastim, Neutropenia
Date of authorisation: 28/03/2022,, , Authorised, Last updated: 04/04/2022
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … leukaemia). Stimufend is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Ritemvia
rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 8, Withdrawn, Last updated: 16/08/2021
under additional monitoring . Biosimilar Biosimilar Biosimilar This is a biosimilar medicine, which is a biological … period. Ritemvia is a biosimilar medicine of MabThera. There … MabThera. There are other biosimilar medicinal products of MabThera … -
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Human medicine European public assessment report (EPAR): Nivestim
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 … -
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Summary of opinion: Tuznue (updated)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 24/06/2022Tuznue was developed as a ‘biosimilar’ medicine. This means that … information can be found under 'Biosimilar medicines - Overview'. biosimilar medicines , see the question-and-answer … Tuznue was developed as a ‘biosimilar’ medicine. This means that …