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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): Sebivo (updated)
telbivudine, Hepatitis B, Chronic
Date of authorisation: 24/04/2007, Revision: 20, Withdrawn, Last updated: 14/01/2021Sebivo : EPAR - Summary for the public … Public Assessment Report (EPAR) for Sebivo will be updated … EMA/CHMP/156189/2012 EMEA/H/C/000713 EPAR summary for the public Sebivo … -
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Human medicine European public assessment report (EPAR): BeneFIX (updated)
Nonacog alfa, Hemophilia B
Date of authorisation: 27/08/1997, Revision: 40, Authorised, Last updated: 11/01/2021information. Abbreviated as EPAR. More information can be found … Public Assessment Report (EPAR) for BeneFIX. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Enbrel (updated)
etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid
Date of authorisation: 02/02/2000, Revision: 63, Authorised, Last updated: 12/01/2021information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Enbrel. It explains … characteristics (also part of the EPAR). The medicine can only be … -
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Human medicine European public assessment report (EPAR): Panretin (updated)
alitretinoin, Sarcoma, Kaposi
Date of authorisation: 11/10/2000, Revision: 17, Withdrawn, Last updated: 11/01/2021Panretin : EPAR - Medicine overview (PDF/637.1 … -
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Human medicine European public assessment report (EPAR): Zometa
zoledronic acid, zoledronic acid monohydrate, Cancer, Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 34, Authorised, Last updated: 14/12/2020public assessment report (EPAR). It explains how the Committee … leaflet (also part of the EPAR) or contact your doctor or … discussion (also part of the EPAR). Expand section Collapse section … -
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Human medicine European public assessment report (EPAR): Simulect (updated)
basiliximab, Graft Rejection, Kidney Transplantation
Date of authorisation: 09/10/1998, Revision: 25, Authorised, Last updated: 05/01/2021information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). It explains how the The … leaflet (also part of the EPAR) or contact your doctor or … -
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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
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): Micardis (updated)
telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 24, Authorised, Last updated: 18/12/2020public assessment report (EPAR). It explains how the Committee … leaflet (also part of the EPAR) or contact your doctor or … discussion (also part of the EPAR). What is Micardis? Micardis … -
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Human medicine European public assessment report (EPAR): Ozempic (updated)
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): Xyrem (updated)
sodium oxybate, Cataplexy, Narcolepsy
Date of authorisation: 13/10/2005, Revision: 31, Authorised, Last updated: 08/01/2021information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Xyrem. It explains how … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Aldara
imiquimod, Condylomata Acuminata, Keratosis, Keratosis, Actinic, Carcinoma, Basal Cell
Date of authorisation: 18/09/1998, Revision: 27, Authorised, Last updated: 15/12/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). It explains how the The … leaflet (also part of the EPAR) or contact your doctor or … -
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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: 04/01/2021information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Bondronat. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Brintellix (updated)
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 16, Authorised, Last updated: 15/01/2021information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Brintellix. It explains … acknowledged. EMA/3075/2014 EMEA/H/C/002717 EPAR summary for the public Brintellix vortioxetine This … -
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Human medicine European public assessment report (EPAR): Toujeo (previously Optisulin) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 26/06/2000, Revision: 31, Authorised, Last updated: 15/01/2021Summary documents Toujeo : EPAR - Medicine overview PDF icon … icon application/pdf h-309-epar_summary_en.pdf 11/05/2009 03/12/2019 EMA/598962/2019 … product characteristics This EPAR was last updated on 15/01/2021 … -
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Human medicine European public assessment report (EPAR): Fycompa (updated)
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 19, Authorised, Last updated: 13/01/2021Fycompa : EPAR - Medicine overview (PDF/134.75 … -
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Human medicine European public assessment report (EPAR): Stalevo (updated)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 17/10/2003, Revision: 27, Authorised, Last updated: 21/12/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Stalevo. It explains … characteristics (also part of the EPAR) for full instructions on … -
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Human medicine European public assessment report (EPAR): Orbactiv
oritavancin diphosphate, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 18/03/2015, Revision: 10, Authorised, Last updated: 18/12/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Orbactiv. It explains … characteristics (also part of the EPAR). What benefits of Orbactiv … -
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Human medicine European public assessment report (EPAR): Rilutek
Riluzole, Amyotrophic Lateral Sclerosis
Date of authorisation: 10/06/1996, Revision: 28, Authorised, Last updated: 10/12/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). It explains how the The … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Gardasil
human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization
Date of authorisation: 20/09/2006, Revision: 43, Authorised, Last updated: 08/12/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Gardasil. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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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
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Zytiga. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): INOmax (updated)
Nitric oxide, Hypertension, Pulmonary, Respiratory Insufficiency
Date of authorisation: 01/08/2001, Revision: 22, Authorised, Last updated: 15/01/2021public assessment report (EPAR) for INOmax. It explains … leaflet (also part of the EPAR) or contact your doctor or … Summary documents INOmax : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): MabThera
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 02/06/1998, Revision: 52, Authorised, Last updated: 11/12/2020Summary documents MabThera : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018,, Revision: 8, Authorised, Last updated: 11/01/2021
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): Travatan
travoprost, Glaucoma, Open-Angle, Ocular Hypertension
Date of authorisation: 27/11/2001, Revision: 29, Authorised, Last updated: 14/12/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Travatan. It explains … leaflet (also part of the EPAR) or contact your doctor or …