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255 results
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,
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, 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,, 
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, 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
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Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 17, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Gamifant (updated)
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,, Refused, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 15, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 1, Authorised, Last updated: 23/03/2021