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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): 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, , Revision: 3, Withdrawn, Last updated: 25/11/2021
First published: 12/10/2020 Last updated: 25/11/2021 EMA/41247 … updated: 25/11/2021 EMA/412474/2020 Click to see translations … PDF/737.48 KB) This EPAR was last updated on 25/11/2021 … -
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Human medicine European public assessment report (EPAR): Remsima
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 32, Authorised, Last updated: 20/02/2023
treatments. Remsima is a ‘biosimilar’ medicine. This means that … as an infusion into a vein lasting one or two hours. All patients … information can be found under 'Biosimilar medicines - Overview'. … -
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Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 5, Authorised, Last updated: 29/03/2023
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): 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): 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): 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
bowel) or the rectum (the last section of the bowel), when … bevacizumab and it is a ‘biosimilar medicine’. This means that … infusion of Zirabev should last 90 minutes, but subsequent … -
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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
First published: 15/08/2017 Last updated: 16/08/2021 EMA/413555/2019 … PDF/731.06 KB) This EPAR was last updated on 16/08/2021 … the European Union On 22 June 2021, the European Commission … -
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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 … infusion of Mvasi should last 90 minutes, but subsequent … 314). Because Mvasi 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): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 1, Authorised, Last updated: 14/09/2021
First published: 16/03/2021 Last updated: 14/09/2021 EMA/70495 … updated: 14/09/2021 EMA/704954/2020 Click to see translations … PDF/135.8 KB) This EPAR was last updated on 14/09/2021 … -
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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): 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): Aybintio
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: 19/08/2020,, , Revision: 6, Authorised, Last updated: 15/12/2022
medicines work. Aybintio is a ‘biosimilar medicine’. This means that … Avastin. For more information on biosimilar medicines, see below. Aybintio … infusion of Aybintio should last 90 minutes, but subsequent … -
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 12, Authorised, Last updated: 24/09/2021
First published: 14/10/2014 Last updated: 14/12 2020 EMA/434801 2020 Click to see translations … European Medicines Agency, 2020. Reproduction is authorised … acknowledged. EMA/434801/2020 EMEA/H/C/002835 Abasaglar1 … -
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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'. … acknowledged. EMA/705248/2020 EMEA/H/C/005188 Yuflyma … -
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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: 12, Authorised, Last updated: 09/09/2022
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … European Medicines Agency, 2020. Reproduction is authorised … -
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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
First published: 03/12/2018 Last updated: 09/11 2020 This EPAR was last updated on 24/02/2023 … -
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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
First published: 12/01/2017 Last updated: 22/01/2019 Click … PDF/542.23 KB) This EPAR was last updated on 22/01/2019 … -
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Human medicine European public assessment report (EPAR): Livogiva
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, , Revision: 1, Authorised, Last updated: 07/01/2021
for Human Use (CHMP) 22-25 June 2020 26/06 2020 Related content Biosimilar medicines: Overview Topics: … European Medicines Agency, 2020. Reproduction is authorised … acknowledged. EMA/349950/2020 EMEA/H/C/005087 Livogiva … -
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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 … neutropenia. Neutropenia lasted on average 1.6 days with … medicines. Because Pelgraz is a biosimilar medicine, the studies on … -
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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): 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 … neutropenia. Neutropenia lasted 1 day on average with both … medicines. Because Fulphila is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Lextemy
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms, Withdrawn, Last updated: 24/02/2021
PDF/734.03 KB) This EPAR was last updated on 24/02/2021 … the European Union On 21 June 2021, the European Commission … medicines work. Lextemy is a ‘biosimilar medicine’. This means that … -
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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 …