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Human medicine European public assessment report (EPAR): Exjade (updated)
deferasirox, beta-Thalassemia, Iron Overload
Date of authorisation: 28/08/2006,
, Revision: 47, Authorised, Last updated: 22/09/2020
Exjade : EPAR - Medicine overview (PDF/87.56 … -
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Human medicine European public assessment report (EPAR): Picato
Ingenol mebutate, Keratosis, Actinic
Date of authorisation: 15/11/2012,
, , Revision: 10, Withdrawn, Last updated: 31/07/2020
Picato : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Taltz
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 10, Authorised, Last updated: 07/07/2020
EMA/171915/2016 EMEA/H/C/003943 EPAR summary for the public Taltz … public assessment report (EPAR) for Taltz. It explains how … characteristics (also part of the EPAR). Taltz EMA/171915/2016 … -
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Human medicine European public assessment report (EPAR): Axumin (updated)
Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging
Date of authorisation: 21/05/2017,, Revision: 9, Authorised, Last updated: 02/09/2020
Axumin EPAR summary 30 Churchill … EMA/240225/2017 EMEA/H/C/004197 EPAR summary for the public Axumin … public assessment report (EPAR) for Axumin. It explains … -
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Human medicine European public assessment report (EPAR): Vemlidy (updated)
tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017,, Revision: 8, Authorised, Last updated: 14/09/2020
EMA/788418/2016 EMEA/H/C/004169 EPAR summary for the public Vemlidy … public assessment report (EPAR) for Vemlidy. It explains … January 2017. The full EPAR for Vemlidy can be found … -
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosylate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, 
, Revision: 10, Authorised, Last updated: 27/08/2020
EMA/627939/2017 EMEA/H/C/004249 EPAR summary for the public Zejula … public assessment report (EPAR) for Zejula. It explains … November 2017. The full EPAR for Zejula can be found on … -
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011,, , Revision: 25, Authorised, Last updated: 28/08/2020
Summary documents Gilenya : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): Zepatier
elbasvir, grazoprevir, Hepatitis C, Chronic
Date of authorisation: 22/07/2016,, Revision: 9, Authorised, Last updated: 17/08/2020
EMA/377766/2016 EMEA/H/C/004126 EPAR summary for the public Zepatier … public assessment report (EPAR) for Zepatier. It explains … characteristics (also part of the EPAR). Zepatier EMA/377766/2016 … -
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Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011,, Revision: 19, Authorised, Last updated: 03/07/2020
EMA/216210/2016 EMEA/H/C/001213 EPAR summary for the public Zoely … public assessment report (EPAR) for Zoely. It explains how … 27 July 2011. The full EPAR for Zoely can be found on … -
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, , Revision: 9, Authorised, Last updated: 26/08/2020
EMA/524256/2015 EMEA/H/C/002734 EPAR summary for the public Cresemba … public assessment report (EPAR) for Cresemba. It explains … Cresemba .> The full EPAR and risk management plan … -
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Human medicine European public assessment report (EPAR): Afstyla (updated)
lonoctocog alfa, Hemophilia A
Date of authorisation: 04/01/2017,, Revision: 7, Authorised, Last updated: 26/08/2020
EMA/753310/2016 EMEA/H/C/004075 EPAR summary for the public Afstyla … public assessment report (EPAR) for Afstyla. It explains … January 2017. The full EPAR for Afstyla can be found … -
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Human medicine European public assessment report (EPAR): Aimovig (updated)
erenumab, Migraine Disorders
Date of authorisation: 26/07/2018,, Revision: 5, Authorised, Last updated: 09/09/2020
public assessment report (EPAR) and made available in all … Aimovig : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , 
, Revision: 19, Authorised, Last updated: 23/09/2020
EMA/468342/2015 EMEA/H/C/002640 EPAR summary for the public Cometriq … public assessment report (EPAR) for Cometriq. It explains … 21 March 2014. The full EPAR and risk management plan … -
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, 
, Revision: 20, Authorised, Last updated: 24/06/2020
EMA/529536/2016 EMEA/H/C/000700 EPAR summary for the public Elaprase … public assessment report (EPAR) for Elaprase. It explains … January 2007. The full EPAR for Elaprase can be found … -
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Human medicine European public assessment report (EPAR): Intuniv
guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity
Date of authorisation: 17/09/2015,, Revision: 7, Authorised, Last updated: 06/07/2020
EMA/597493/2015 EMEA/H/C/003759 EPAR summary for the public Intuniv … public assessment report (EPAR) for Intuniv. It explains … September 2015. The full EPAR and risk management plan … -
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Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 8, Authorised, Last updated: 21/07/2020
EMA/787689/2015 EMEA/H/C/002616 EPAR summary for the public Wakix … public assessment report (EPAR) for Wakix. It explains how … 31 March 2016. The full EPAR and risk management plan … -
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Human medicine European public assessment report (EPAR): Zurampic
lesinurad, Hyperuricemia
Date of authorisation: 18/02/2016,, Revision: 4, Withdrawn, Last updated: 31/07/2020
Zurampic : EPAR - Summary for the public … -
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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: 7, Authorised, Last updated: 08/09/2020
EMA/265548/2017 EMEA/H/C/004192 EPAR summary for the public Erelzi … public assessment report (EPAR) for Erelzi. It explains … characteristics (also part of the EPAR). Erelzi EMA/265548/2017 … -
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Human medicine European public assessment report (EPAR): EndolucinBeta
lutetium (177 Lu) chloride, Radionuclide Imaging
Date of authorisation: 06/07/2016,, Revision: 6, Authorised, Last updated: 17/08/2020
public assessment report (EPAR) and made available in all … documents EndolucinBeta : EPAR - Medicine overview Microsoft … -
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, , Revision: 16, Authorised, Last updated: 21/09/2020
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Human medicine European public assessment report (EPAR): Refixia
Nonacog beta pegol, Hemophilia B
Date of authorisation: 02/06/2017,, Revision: 1, Authorised, Last updated: 17/06/2020
EMA/212538/2017 EMEA/H/C/004178 EPAR summary for the public Refixia … public assessment report (EPAR) for Refixia. It explains … characteristics (also part of the EPAR). Patients or their carers … -
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Human medicine European public assessment report (EPAR): Descovy
emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/04/2016,, Revision: 16, Authorised, Last updated: 16/06/2020
EMA/169100/2016 EMEA/H/C/004094 EPAR summary for the public Descovy … public assessment report (EPAR) for Descovy. It explains … characteristics (also part of the EPAR). Descovy EMA/169100/2016 … -
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Human medicine European public assessment report (EPAR): Elocta (updated)
efmoroctocog alfa, Hemophilia A
Date of authorisation: 18/11/2015,, Revision: 10, Authorised, Last updated: 03/09/2020
Summary documents Elocta : EPAR - Medicine overview PDF icon … EMA/660642/2015 Generic Elocta : EPAR - Risk-management-plan summary … -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/09/2017,, Revision: 10, Authorised, Last updated: 02/09/2020
Summary documents Tecentriq : EPAR - Medicine overview PDF icon … EMA/533341/2019 Generic Tecentriq : EPAR - Risk-management-plan summary … product characteristics This EPAR was last updated on 02/09/2020 … -
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Human medicine European public assessment report (EPAR): Idelvion
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 7, Authorised, Last updated: 29/06/2020
EMA/196132/2016 EMEA/H/C/003955 EPAR summary for the public Idelvion … public assessment report (EPAR) for Idelvion. It explains … characteristics (also part of the EPAR). Idelvion EMA/196132/2016 …