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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Paediatric investigation plans Remove Paediatric investigation plans filter

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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: 8, Authorised, Last updated: 11/11/2020
List item

Human medicine European public assessment report (EPAR): Atriance

nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007, , , Revision: 24, Authorised, Last updated: 04/12/2020
List item

Human medicine European public assessment report (EPAR): ATryn

Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006, , , Revision: 16, Withdrawn, Last updated: 02/07/2019
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Human medicine European public assessment report (EPAR): Ayvakyt

avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020, , , Revision: 1, Authorised, Last updated: 06/11/2020
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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, , Authorised, Last updated: 21/02/2020
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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: 1, Authorised, Last updated: 20/11/2020
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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: 1, Authorised, Last updated: 16/09/2020
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Human medicine European public assessment report (EPAR): Besponsa

inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017, , , Revision: 7, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 1, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Blincyto

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 11, Authorised, Last updated: 22/01/2021
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Veterinary medicine European public assessment report (EPAR): Bluevac BTV (previously known as Bluevac BTV8)

bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated], Sheep, Cattle
Date of authorisation: 14/04/2011, , Revision: 7, Authorised, Last updated: 27/10/2020
List item

Human medicine European public assessment report (EPAR): Bortezomib Accord

bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015, , Revision: 8, Authorised, Last updated: 02/02/2021
List item

Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi

bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019, , Revision: 3, Authorised, Last updated: 18/01/2021
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Human medicine European public assessment report (EPAR): Bortezomib Hospira

bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, , Revision: 9, Authorised, Last updated: 19/10/2020
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Human medicine European public assessment report (EPAR): Bortezomib Sun (updated)

bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, , Revision: 10, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Brineura

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 4, Authorised, Last updated: 12/06/2020
List item

Human medicine European public assessment report (EPAR): Bronchitol

mannitol, Cystic Fibrosis
Date of authorisation: 13/04/2012, , Revision: 15, Authorised, Last updated: 28/10/2020
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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: 8, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord

cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020, , , Authorised, Last updated: 28/10/2020
List item

Human medicine European public assessment report (EPAR): Cablivi

Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018, , , Revision: 4, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Cabometyx

cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016, , , Revision: 9, Authorised, Last updated: 11/11/2020
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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: 12, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Capecitabine Medac

capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012, , , Revision: 10, Authorised, Last updated: 05/08/2020
List item

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
List item

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: 13, Authorised, Last updated: 29/07/2020