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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): 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): 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): Benepali (updated)
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,, Revision: 20, Authorised, Last updated: 01/06/2023
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): 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): Cyltezo
adalimumab, Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,, , Revision: 2, Withdrawn, Last updated: 06/03/2019
under additional monitoring . Biosimilar Biosimilar Biosimilar This is a biosimilar medicine, which is a biological … -
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Human medicine European public assessment report (EPAR): Solymbic
adalimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,, , Revision: 2, Withdrawn, Last updated: 05/03/2019
under additional monitoring . Biosimilar Biosimilar Biosimilar This is a biosimilar medicine, which is a biological … -
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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): Truxima
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017,, Revision: 19, Authorised, Last updated: 31/01/2023
rituximab. Truxima is a ‘biosimilar medicine’. This means that … MabThera. For more information on biosimilar medicines, see here . Expand … responses. Because Truxima is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Onbevzi
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021,, , Revision: 4, Authorised, Last updated: 11/04/2023
medicines work. Onbevzi is a ‘biosimilar medicine’. This means that … comparable. Because Onbevzi is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Onbevzi has a … -
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Human medicine European public assessment report (EPAR): Oyavas
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 4, Authorised, Last updated: 05/01/2023
medicines work. Oyavas is a ‘biosimilar medicine’. This means that … Avastin. For more information on biosimilar medicines, see here . Oyavas … comparable. Because Oyavas is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Grasustek
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 4, Authorised, Last updated: 31/03/2023
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): Imraldi
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, Revision: 20, Authorised, Last updated: 24/03/2023
substance adalimumab and is a ‘biosimilar medicine’. This means that … year. Because Imraldi is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Imraldi has a … -
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Human medicine European public assessment report (EPAR): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, , Revision: 6, 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'. … teriparatide. Terrosa is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Ranivisio
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, , Revision: 2, 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'. … neovascularisation. Ranivisio is a ‘biosimilar medicine’. This means that … -
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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): Hukyndra
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,, Revision: 4, Authorised, Last updated: 09/03/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … pharmacist. Hukyndra 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): Nepexto
etanercept, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies; Spondylitis, Ankylosing; Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 8, Authorised, Last updated: 19/09/2022
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): 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): Amgevita
adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,, Revision: 11, Authorised, Last updated: 18/01/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … substance adalimumab and is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Ziextenzo
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, , Revision: 5, Authorised, Last updated: 26/07/2022
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): Sondelbay
teriparatide, Osteoporosis
Date of authorisation: 24/03/2022,, , Authorised, Last updated: 16/06/2022
steroid). Sondelbay is a ‘biosimilar medicine’. This means that … Forsteo. For more information on biosimilar medicines, see here . Sondelbay … Forsteo. Because Sondelbay is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Libmyris
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 11/01/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … pharmacist. Libmyris is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Abevmy
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 5, Authorised, Last updated: 15/12/2022
medicines work. Abevmy is a ‘biosimilar medicine’. This means that … Avastin. For more information on biosimilar medicines, see here . Abevmy … comparable. Because Abevmy is a biosimilar medicine, the studies on …