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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,
, 
, Revision: 8, Authorised, Last updated: 23/01/2023
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): Insulin lispro Sanofi (updated)
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,, Revision: 8, Authorised, Last updated: 22/03/2023
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): Truvelog Mix 30 (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,, , Revision: 1, Authorised, Last updated: 23/03/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … Truvelog Mix 30 is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Fulphila
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 10, Authorised, Last updated: 14/11/2022
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 … -
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Human medicine European public assessment report (EPAR): Pelmeg
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 7, Authorised, Last updated: 24/02/2023
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): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 7, Authorised, Last updated: 24/02/2023
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): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 10, Authorised, Last updated: 13/12/2022
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): Zessly
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, Revision: 10, Authorised, Last updated: 12/12/2022
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): 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: 14, Authorised, Last updated: 05/01/2023
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 … -
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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: 12, Authorised, Last updated: 05/01/2023
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): Nivestim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010,, Revision: 26, Authorised, Last updated: 12/01/2023
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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Human medicine European public assessment report (EPAR): Kauliv (updated)
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023,, , Authorised, Last updated: 07/03/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … steroid). Kauliv is a ‘biosimilar medicine’. This means that … -
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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: 5, Authorised, Last updated: 05/01/2023
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): 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): Rixathon
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, Revision: 9, Authorised, Last updated: 31/08/2022
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 … -
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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: 13, Authorised, Last updated: 05/12/2022
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 … -
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Human medicine European public assessment report (EPAR): Movymia
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, Revision: 10, Authorised, Last updated: 20/01/2022
teriparatide. Movymia is a ‘biosimilar medicine’. This means that … Forsteo. For more information on biosimilar medicines, see the question-and-answer … activity. Because Movymia 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): 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): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, Revision: 23, Authorised, Last updated: 06/03/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … enoxaparin sodium and 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: 11, Authorised, Last updated: 17/10/2022
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): Benepali
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,, Revision: 19, Authorised, Last updated: 13/02/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … substance etanercept and is a ‘biosimilar medicine’. This means that … -
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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: 11, Authorised, Last updated: 31/08/2022
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 … -
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Human medicine European public assessment report (EPAR): Yuflyma
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021,, Revision: 9, Authorised, Last updated: 30/01/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … pharmacist. Yuflyma is a ‘biosimilar medicine’. This means that … -
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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 …