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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, Revision: 8, Withdrawn, Last updated: 29/01/2021
Summary documents Halimatoz : EPAR - Medicine overview PDF icon … Public Assessment Report (EPAR) for Halimatoz will be updated … -
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 12, Authorised, Last updated: 26/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Taltz. It explains how … characteristics (also part of the EPAR). How does Taltz work? The … -
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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
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Spinraza. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Truberzi (updated)
eluxadoline, Irritable Bowel Syndrome, Diarrhea
Date of authorisation: 19/09/2016,, Revision: 6, Withdrawn, Last updated: 25/02/2021
Truberzi : EPAR - Summary for the public … Public Assessment Report (EPAR) for Truberzi will be updated … EMA/CHMP/517539/2016 EMEA/H/C/004098 EPAR summary for the public Truberzi … -
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 40, Authorised, Last updated: 01/03/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Glivec. It explains … Summary documents Glivec : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 11, Authorised, Last updated: 23/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Galafold. It explains … characteristics (also part of the EPAR). How does Galafold work? The … -
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 9, Authorised, Last updated: 23/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Idelvion. It explains … characteristics (also part of the EPAR). How does Idelvion work? Patients … -
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Human medicine European public assessment report (EPAR): Keytruda
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: 31, Authorised, Last updated: 28/01/2021
Summary documents Keytruda : EPAR - Medicine overview PDF icon … -
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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
Udenyca : EPAR - Medicine overview (PDF/630.11 … public assessment report (EPAR) and made available in all … -
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Human medicine European public assessment report (EPAR): Ozempic
semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018,, Revision: 4, Authorised, Last updated: 11/01/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Ozempic. It explains … 8 February 2018. The full EPAR for Ozempic can be found … -
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Human medicine European public assessment report (EPAR): Ocrevus
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018,, Revision: 9, Authorised, Last updated: 22/01/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Ocrevus. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011,
, , Revision: 28, Authorised, Last updated: 04/02/2021
Summary documents Gilenya : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): Xarelto (updated)
rivaroxaban, Arthroplasty, Replacement, Venous Thromboembolism
Date of authorisation: 30/09/2008,, , Revision: 33, Authorised, Last updated: 02/02/2021
Summary documents Xarelto : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): Cinryze (updated)
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 19, Authorised, Last updated: 24/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Cinryze. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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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
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Inhixa. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Tookad (updated)
padeliporfin di-potassium, Prostatic Neoplasms
Date of authorisation: 10/11/2017,, Revision: 2, Authorised, Last updated: 01/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Tookad. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Axumin
Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging
Date of authorisation: 21/05/2017,, Revision: 10, Authorised, Last updated: 11/01/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Axumin. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 12, Authorised, Last updated: 23/02/2021
Tecentriq : EPAR - Medicine overview (PDF/121.55 … -
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, , Revision: 4, Authorised, Last updated: 27/01/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Lutathera. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Enzepi (updated)
pancreas powder, Exocrine Pancreatic Insufficiency
Date of authorisation: 29/06/2016,, Revision: 1, Withdrawn, Last updated: 17/02/2021
Summary documents Enzepi : EPAR - Summary for the public … product characteristics This EPAR was last updated on 17/02/2021 … EMEA/H/C/002070 - T/01 Enzepi : EPAR - Product Information PDF … -
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Human medicine European public assessment report (EPAR): Kevzara (updated)
sarilumab, Arthritis, Rheumatoid
Date of authorisation: 23/06/2017,, Revision: 5, Authorised, Last updated: 10/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Kevzara. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Trulicity (updated)
dulaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 21/11/2014,, Revision: 12, Authorised, Last updated: 01/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Trulicity. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, , Revision: 12, Authorised, Last updated: 14/01/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Kisplyx. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 11, Authorised, Last updated: 24/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Neparvis. It explains … characteristics (also part of the EPAR). How does Neparvis work? The … -
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , 
, Revision: 20, Authorised, Last updated: 22/02/2021
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Cometriq. It explains … leaflet (also part of the EPAR) or contact your doctor or …