For help on how to get the results you want, see our search tips.
196 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Withdrawn applications Remove Withdrawn applications filter
Orphan designations Remove Orphan designations filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Biosimilar Remove Biosimilar filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,
, 
, Revision: 11, Authorised, Last updated: 03/03/2021
-
List item
Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, 
, 
, Revision: 18, Authorised, Last updated: 02/03/2021
-
List item
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: 16, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,, , Revision: 11, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Vpriv (updated)
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, , Revision: 14, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 17, Authorised, Last updated: 24/02/2021
-
List item
Human medicine European public assessment report (EPAR): Prepandrix (updated)
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
-
List item
Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 22, Authorised, Last updated: 23/02/2021
-
List item
Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, Revision: 13, Authorised, Last updated: 23/02/2021
-
List item
Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 3, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Kanjinti (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 7, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 11, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 20, Authorised, Last updated: 16/02/2021
-
List item
Human medicine European public assessment report (EPAR): Udenyca (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 3, Withdrawn, Last updated: 15/02/2021
-
List item
Human medicine European public assessment report (EPAR): Ritemvia (updated)
rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 8, Authorised, Last updated: 11/02/2021
-
List item
Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 10, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, , Revision: 8, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Insulin aspart Sanofi (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,, Revision: 1, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 2, Authorised, Last updated: 09/02/2021
-
List item
Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 9, Authorised, Last updated: 08/02/2021
-
List item
Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 16, Authorised, Last updated: 05/02/2021
-
List item
Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, , Revision: 8, Authorised, Last updated: 02/02/2021
-
List item
Human medicine European public assessment report (EPAR): Ogivri
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 5, Authorised, Last updated: 29/01/2021
-
List item
Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
-
List item
Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 13, Authorised, Last updated: 28/01/2021