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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter Referrals Remove Referrals filter

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

cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016, , , Revision: 10, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Reblozyl (updated)

Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia
Date of authorisation: 25/06/2020, , , Revision: 1, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Zolgensma (updated)

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Equidacent (updated)

bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020, , , Revision: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Zercepac (updated)

trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020, , , Revision: 3, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Coagadex (updated)

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , , Revision: 7, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Opsumit (updated)

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 17, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , , Revision: 3, Authorised, Last updated: 09/04/2021
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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: 6, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Brineura (updated)

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 5, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Kymriah (updated)

tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018, , , Revision: 4, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , , Revision: 13, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Exviera (updated)

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , , Revision: 19, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Cresemba (updated)

isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015, , Revision: 10, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Aybintio (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: 19/08/2020, , , Revision: 2, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Epclusa (updated)

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , , Revision: 14, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)

6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, , Revision: 12, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Amglidia (updated)

glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018, , Revision: 4, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)

adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018, , , Revision: 5, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): Trazimera (updated)

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018, , , Revision: 7, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , , , Revision: 21, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Strensiq (updated)

asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015, , , , Revision: 14, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Lenvima (updated)

lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015, , , Revision: 15, Authorised, Last updated: 25/03/2021
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2 (updated)

inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006, , Revision: 8, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Vidaza (updated)

azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008, , Revision: 21, Authorised, Last updated: 23/03/2021