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Human medicine European public assessment report (EPAR): Luxturna (updated)
voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa
Date of authorisation: 22/11/2018,,
, Revision: 3, Authorised, Last updated: 05/01/2021
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Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)
telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 10, Authorised, Last updated: 05/01/2021
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Human medicine European public assessment report (EPAR): Erelzi (updated)
etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,,
, Revision: 8, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 16, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Combivir (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 18/03/1998, Revision: 31, Authorised, Last updated: 04/01/2021 -
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Human medicine European public assessment report (EPAR): Hexacima (updated)
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 22, Authorised, Last updated: 04/01/2021 -
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Human medicine European public assessment report (EPAR): Bondronat (updated)
ibandronic acid, Hypercalcemia, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone
Date of authorisation: 25/06/1996, Revision: 30, Authorised, Last updated: 04/01/2021 -
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
Upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, Revision: 2, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Humira (updated)
adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 08/09/2003, Revision: 80, Authorised, Last updated: 04/01/2021 -
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,,
, Revision: 7, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 11, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 15, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Alofisel (updated)
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,,
, Revision: 6, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Jakavi (updated)
ruxolitinib (as phosphate), Myeloproliferative Disorders, Polycythemia Vera
Date of authorisation: 23/08/2012, Revision: 22, Authorised, Last updated: 04/01/2021 -
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Human medicine European public assessment report (EPAR): Lonsurf (updated)
trifluridine, tipiracil hydrochloride, Colorectal Neoplasms
Date of authorisation: 25/04/2016, Revision: 6, Authorised, Last updated: 04/01/2021 -
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Human medicine European public assessment report (EPAR): Pegasys (updated)
peginterferon alfa-2a, Hepatitis C, Chronic, Hepatitis B, Chronic
Date of authorisation: 20/06/2002, Revision: 41, Authorised, Last updated: 22/12/2020 -
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,,
, Revision: 4, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Izba (updated)
travoprost, Ocular Hypertension, Glaucoma, Open-Angle
Date of authorisation: 20/02/2014, Revision: 5, Authorised, Last updated: 22/12/2020 -
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,,
, Revision: 7, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Skilarence (updated)
dimethyl fumarate, Psoriasis
Date of authorisation: 23/06/2017, Revision: 6, Authorised, Last updated: 22/12/2020 -
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Human medicine European public assessment report (EPAR): Anoro Ellipta (previously Anoro) (updated)
umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 15, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Plegridy (updated)
peginterferon beta-1a, Multiple Sclerosis
Date of authorisation: 17/07/2014, Revision: 20, Authorised, Last updated: 22/12/2020 -
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Human medicine European public assessment report (EPAR): Zytiga (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 23, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 30, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Sixmo (updated)
Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019,, Revision: 2, Authorised, Last updated: 21/12/2020