103 results
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Human medicine European public assessment report (EPAR): Pelgraz (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,
, Revision: 11, Authorised, Last updated: 15/09/2023
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): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, Revision: 8, Authorised, Last updated: 05/09/2023
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) (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,
, , Revision: 3, Authorised, Last updated: 27/09/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … diabetes. Kirsty is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Rixathon (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, Revision: 11, Authorised, Last updated: 18/09/2023
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 (updated)
adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018,, Revision: 15, Authorised, Last updated: 08/09/2023
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): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, , Revision: 6, Authorised, Last updated: 28/07/2023
teriparatide. Terrosa is a ‘biosimilar medicine’. This means that … activity. Because Terrosa is a biosimilar medicine, the studies on … teriparatide. Terrosa is a ‘biosimilar medicine’. This means that … -
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Human medicine European public assessment report (EPAR): Riximyo (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,, Revision: 13, Authorised, Last updated: 18/09/2023
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): Ranivisio (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, , Revision: 3, Authorised, Last updated: 18/09/2023
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): Zessly
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, Revision: 11, Authorised, Last updated: 14/07/2023
methotrexate. Zessly is a ‘biosimilar medicine’. This means that … Remicade. For more information on biosimilar medicines, see 'Related content' … Remicade). Because Zessly is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Truvelog Mix 30
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,, , Revision: 2, Authorised, Last updated: 06/07/2023
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): Kauliv
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023,, , Authorised, Last updated: 07/03/2023
steroid). Kauliv is a ‘biosimilar medicine’. This means that … Forsteo. For more information on biosimilar medicines, see here . Kauliv … Forsteo. Because Kauliv is a biosimilar medicine, the studies on … -
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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
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 … -
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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: 13, Authorised, Last updated: 04/08/2023
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 … -
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, Revision: 9, Authorised, Last updated: 22/09/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … glargine. Semglee is a ‘biosimilar medicine’. This means that … -
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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: 27, Authorised, Last updated: 23/05/2023
marrow. Nivestim is a ‘biosimilar’ medicine. This means that … Neupogen. For more information on biosimilar medicines, see below. Nivestim … Neupogen. Because Nivestim is a biosimilar medicine the studies on effectiveness … -
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Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies; Spondylitis, Ankylosing; Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 10, Authorised, Last updated: 07/09/2023
pharmacist. Nepexto is a ‘biosimilar medicine’. This means that … Enbrel. For more information on biosimilar medicines, see here . Nepexto … Enbrel. Because Nepexto is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Bekemv
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 19/04/2023,, Revision: 1, Authorised, Last updated: 06/07/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … dark urine. Bekemv 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): Epysqli
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,, , Authorised, Last updated: 31/05/2023
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … cells). Epysqli is a ‘biosimilar medicine’. This means that … -
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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: 13, Authorised, Last updated: 20/09/2023
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 … -
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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: 18, Authorised, Last updated: 02/02/2023
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): Benepali (updated)
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,, Revision: 21, Authorised, Last updated: 14/09/2023
substance etanercept and is a ‘biosimilar medicine’. This means that … Enbrel. For more information on biosimilar medicines, see related information … activity. Because Benepali is a biosimilar medicine, all the studies … -
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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): Ogivri (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018,, Revision: 10, Authorised, Last updated: 12/09/2023
gastric cancers. Ogivri is a ‘biosimilar medicine’. This means that … indications. Because Ogivri is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Ogivri has a highly … -
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 14, Authorised, Last updated: 24/07/2023
substance filgrastim, is a ‘biosimilar medicine’. This means that … with EU requirements for biosimilar medicines, Accofil has been … substance filgrastim, is a ‘biosimilar medicine’. This means that …