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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,
, Revision: 10, Authorised, Last updated: 01/12/2023
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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: 11, Authorised, Last updated: 01/12/2023
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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: 4, Authorised, Last updated: 01/12/2023
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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: 16, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Yuflyma (updated)
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: 12, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Abevmy (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: 21/04/2021,, , Revision: 7, Authorised, Last updated: 30/11/2023
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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: 14, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, Revision: 19, Authorised, Last updated: 29/11/2023
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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: 12, Authorised, Last updated: 29/11/2023
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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: 20, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Ruxience (updated)
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 11, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, Revision: 12, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Zabdeno (updated)
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, 
, Revision: 5, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Mvabea (updated)
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Revision: 4, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Herwenda (updated)
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023,, , Authorised, Last updated: 23/11/2023
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal (updated)
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,, Revision: 24, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Binocrit (updated)
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 22, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Obizur (updated)
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 11, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Fulphila (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, Revision: 11, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Tyruko (updated)
natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023,, , Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Kauliv (updated)
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023,, , Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Livmarli (updated)
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,, 
, , Revision: 3, Authorised, Last updated: 13/11/2023
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 13, Authorised, Last updated: 09/11/2023
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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: 6, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Zokinvy (updated)
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,, , , Revision: 2, Authorised, Last updated: 09/11/2023