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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine Referrals Remove Referrals filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Withdrawn applications Remove Withdrawn applications filter Summaries of opinion Remove Summaries of opinion filter

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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: 9, Authorised, Last updated: 16/03/2022
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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
List item

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Date of authorisation: 15/09/2008, , Revision: 8, Withdrawn, Last updated: 19/01/2017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): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 7, Authorised, Last updated: 25/10/2023
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Human medicine European public assessment report (EPAR): Blincyto (updated)

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 18, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Blitzima

rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017, , Revision: 18, Authorised, Last updated: 02/02/2023
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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
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Human medicine European public assessment report (EPAR): Brineura

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Bylvay

Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021, , , , Revision: 3, Authorised, Last updated: 05/07/2023
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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): Cablivi

Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018, , Revision: 8, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Cabometyx

cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016, , Revision: 18, Authorised, Last updated: 10/10/2023
List item

Human medicine European public assessment report (EPAR): Carvykti

ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022, , , , Revision: 4, Authorised, Last updated: 26/07/2023
List item

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
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Human medicine European public assessment report (EPAR): Cerdelga

eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015, , , Revision: 16, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017, , , , Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Coagadex

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , Revision: 9, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Cometriq

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , Revision: 28, Authorised, Last updated: 12/10/2023
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Human medicine European public assessment report (EPAR): Cresemba (updated)

isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015, , Revision: 17, Authorised, Last updated: 13/11/2023
List item

Human medicine European public assessment report (EPAR): Crysvita

Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
Date of authorisation: 19/02/2018, , Revision: 11, Authorised, Last updated: 06/07/2023
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Human medicine European public assessment report (EPAR): Cyltezo

adalimumab, Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 10/11/2017, , , Revision: 2, Withdrawn, Last updated: 06/03/2019
List item

Human medicine European public assessment report (EPAR): Cystadrops

mercaptamine hydrochloride, Cystinosis
Date of authorisation: 18/01/2017, , Revision: 8, Authorised, Last updated: 20/09/2021
List item

Human medicine European public assessment report (EPAR): Dacogen

decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012, , Revision: 16, Authorised, Last updated: 20/07/2021
List item

Human medicine European public assessment report (EPAR): Daklinza

daclatasvir dihydrochloride, Hepatitis C, Chronic
Date of authorisation: 22/08/2014, , Revision: 15, Withdrawn, Last updated: 30/08/2019
List item

Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , Revision: 21, Authorised, Last updated: 20/11/2023