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Human medicine European public assessment report (EPAR): Atazanavir Krka
atazanavir (as sulfate), HIV Infections
Date of authorisation: 25/03/2019,
, Revision: 2, Authorised, Last updated: 07/06/2023
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Human medicine European public assessment report (EPAR): Atazanavir Mylan
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 14, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 9, Authorised, Last updated: 09/02/2022
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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,
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, Revision: 7, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 5, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 7, Authorised, Last updated: 05/10/2023
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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
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Human medicine European public assessment report (EPAR): Bemfola
follitropin alfa, Anovulation
Date of authorisation: 26/03/2014,, Revision: 10, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Benepali
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,, Revision: 21, Authorised, Last updated: 14/09/2023
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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): Biograstim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 8, Withdrawn, Last updated: 19/01/2017
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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): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 13, Authorised, Last updated: 25/03/2022
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 5, Authorised, Last updated: 01/09/2021
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 09/10/2023
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 09/09/2021
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 9, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 6, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 5, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 03/08/2023
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 13, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Capecitabine SUN
capecitabine, Stomach Neoplasms; Breast Neoplasms; Colonic Neoplasms; Colorectal Neoplasms
Date of authorisation: 21/06/2013,, Revision: 3, Withdrawn, Last updated: 22/12/2016
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Human medicine European public assessment report (EPAR): Capecitabine Teva
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 08/09/2021
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Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 9, Authorised, Last updated: 24/11/2023