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Human medicine European public assessment report (EPAR): Nivestim (updated)
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 … pharmacovigilance data 23/04/2020 18/11 2020 SmPC and PL Each pre filled … -
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Human medicine European public assessment report (EPAR): Onbevzi (updated)
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: 3, Authorised, Last updated: 05/01/2023
medicines work. Onbevzi is a ‘biosimilar medicine’. This means that … infusion of Onbevzi should last 90 minutes, but subsequent … comparable. Because Onbevzi is a biosimilar medicine, the studies on … -
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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): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, , Revision: 10, Authorised, Last updated: 15/07/2022
First published: 06/08/2018 Last updated: 15/04 2020 This EPAR was last updated on 15/07/2022 … -
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Human medicine European public assessment report (EPAR): Zercepac
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 7, Authorised, Last updated: 09/02/2022
cancers. Zercepac is a ‘biosimilar medicine’. This means that … Herceptin). Because Zercepac is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Zercepac has a … -
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Human medicine European public assessment report (EPAR): Rituzena (previously Tuxella)
rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 7, Withdrawn, Last updated: 08/07/2019
First published: 15/08/2017 Last updated: 26/09/2017 EMA/327752/2017 … PDF/557.5 KB) This EPAR was last updated on 08/07/2019 … -
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 13/02/2020,, , Revision: 4, Authorised, Last updated: 29/10/2021
substance adalimumab and is a ‘biosimilar medicine’. This means that … Humira. Because Amsparity is a biosimilar medicine, the studies on … with EU requirements for biosimilar medicines, Amsparity has … -
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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): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 13, Authorised, Last updated: 24/06/2022
substance filgrastim, is a ‘biosimilar medicine’. This means that … neutropenia. Severe neutropenia lasted on average for 1.4 days … with EU requirements for biosimilar medicines, Accofil has been … -
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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: 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): 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): Truxima (updated)
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
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … information can be found under 'Biosimilar medicines - Overview'. … acknowledged. EMA/563302/2020 EMEA/H/C/004112 Truxima … -
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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): 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): Inpremzia
insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022,, , Authorised, Last updated: 23/02/2022
human. Inpremzia is a ‘biosimilar medicine’. This means that … Actrapid. For more information on biosimilar medicines, see here . Expand … vein. Because Inpremzia is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Kromeya
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Colitis, Ulcerative; Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 4, Withdrawn, Last updated: 25/03/2020
First published: 26/04/2019 Last updated: 24/03 2020 EMA/591446/2019 Click to … PDF/727.14 KB) This EPAR was last updated on 25/03 2020 … -
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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 … neutropenia. Severe neutropenia lasted on average for 1.4 days which … with EU requirements for biosimilar medicines, Grastofil has … -
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 15, Authorised, Last updated: 23/01/2023
First published: 19/10/2020 This EPAR was last updated on 23/01/2023 … filgrastim. Ratiograstim is a ‘biosimilar’ medicine. This means that … For more information on biosimilar medicines, see the question-and-answer … -
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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): Vegzelma
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: 17/08/2022,, , Revision: 1, Authorised, Last updated: 26/09/2022
topotecan. Vegzelma is a ‘biosimilar medicine’. This means that … Avastin. For more information on biosimilar medicines, see here . Vegzelma … infusion of Vegzelma should last 90 minutes, but subsequent … -
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Human medicine European public assessment report (EPAR): Oyavas (updated)
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 … infusion of Oyavas should last 90 minutes, but subsequent … -
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Human medicine European public assessment report (EPAR): Grasustek
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 3, Authorised, Last updated: 10/08/2022
information can be found under 'Biosimilar medicines - Overview'. biosimilar medicine ’. This means … neutropenia. Severe neutropenia lasted just over one-and-a-half … -
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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 … infusion of Abevmy should last 90 minutes, but subsequent … -
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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: 4, Authorised, Last updated: 15/12/2022
medicines work. Alymsys is a ‘biosimilar medicine’. This means that … infusion of Alymsys should last 90 minutes, but subsequent … comparable. Because Alymsys is a biosimilar medicine, the studies on … -
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Human medicine European public assessment report (EPAR): Amgevita (updated)
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 …