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Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Pelgraz (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,
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, Revision: 5, Authorised, Last updated: 25/05/2020
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Human medicine European public assessment report (EPAR): Ongentys (updated)
opicapone, Parkinson Disease
Date of authorisation: 24/06/2016,, Revision: 5, Authorised, Last updated: 20/05/2020
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Human medicine European public assessment report (EPAR): Waylivra (updated)
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, 
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, Revision: 2, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Verkazia (updated)
ciclosporin, Conjunctivitis, Keratitis
Date of authorisation: 06/07/2018,
, , Revision: 3, Authorised, Last updated: 19/05/2020
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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: 5, Authorised, Last updated: 19/05/2020
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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: 5, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Vosevi (updated)
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 8, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Dengvaxia (updated)
chimeric yellow fever dengue virus serotype 1 (live, attenuated) / chimeric yellow fever dengue virus serotype 2 (live, attenuated) / chimeric yellow fever dengue virus serotype 3 (live, attenuated) / chimeric yellow fever dengue virus serotype 4 (live, attenuated), Dengue
Date of authorisation: 12/12/2018,, Revision: 2, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 20, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 8, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Sovaldi (updated)
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, , Revision: 20, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Kolbam (updated)
cholic acid, Metabolism, Inborn Errors
Date of authorisation: 20/11/2015,, , 
, Revision: 14, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Gazyvaro (updated)
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, , Revision: 10, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Naglazyme (updated)
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, , Revision: 16, Authorised, Last updated: 18/05/2020
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, , Revision: 13, Authorised, Last updated: 18/05/2020
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Human medicine European public assessment report (EPAR): Xofigo (updated)
radium Ra223 dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,
, , Revision: 11, Authorised, Last updated: 18/05/2020
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 8, Authorised, Last updated: 15/05/2020
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 3, Authorised, Last updated: 13/05/2020
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Human medicine European public assessment report (EPAR): Quofenix (updated)
delafloxacin meglumine, Skin Diseases, Bacterial
Date of authorisation: 16/12/2019,, Revision: 1, Authorised, Last updated: 12/05/2020
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Human medicine European public assessment report (EPAR): Senshio (updated)
ospemifene, Postmenopause
Date of authorisation: 14/01/2015,, Revision: 10, Authorised, Last updated: 12/05/2020
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Human medicine European public assessment report (EPAR): Kevzara (updated)
sarilumab, Arthritis, Rheumatoid
Date of authorisation: 23/06/2017,, Revision: 3, Authorised, Last updated: 12/05/2020
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Human medicine European public assessment report (EPAR): Respreeza (updated)
alpha1-proteinase inhibitor (human), Genetic Diseases, Inborn, Lung Diseases
Date of authorisation: 20/08/2015,, Revision: 7, Authorised, Last updated: 11/05/2020
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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: 13, Authorised, Last updated: 11/05/2020
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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: 6, Authorised, Last updated: 08/05/2020
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Human medicine European public assessment report (EPAR): Strensiq (updated)
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 12, Authorised, Last updated: 08/05/2020