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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,
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, Revision: 3, Authorised, Last updated: 07/08/2020
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 5, Authorised, Last updated: 06/08/2020
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, 
, , Revision: 6, Authorised, Last updated: 04/08/2020
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Human medicine European public assessment report (EPAR): Kisqali (updated)
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017,, Revision: 6, Authorised, Last updated: 03/08/2020
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Human medicine European public assessment report (EPAR): Shingrix (updated)
Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster
Date of authorisation: 21/03/2018,, Revision: 4, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 1, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesylate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, 
, Revision: 11, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 17, Authorised, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 22, Authorised, Last updated: 29/07/2020
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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: 21, Authorised, Last updated: 29/07/2020
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , , Revision: 17, Authorised, Last updated: 29/07/2020
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Human medicine European public assessment report (EPAR): Ajovy (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 3, Authorised, Last updated: 29/07/2020
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Human medicine European public assessment report (EPAR): Ofev (updated)
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 14, Authorised, Last updated: 28/07/2020
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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: 9, Authorised, Last updated: 28/07/2020
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Human medicine European public assessment report (EPAR): Fetcroja (updated)
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 1, Authorised, Last updated: 28/07/2020
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Human medicine European public assessment report (EPAR): Lyumjev (previously Liumjev) (updated)
insulin lispro, Diabetes Mellitus
Date of authorisation: 24/03/2020,, Revision: 1, Authorised, Last updated: 27/07/2020
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 7, Authorised, Last updated: 27/07/2020
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Human medicine European public assessment report (EPAR): Halimatoz (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, 
, Revision: 7, Authorised, Last updated: 27/07/2020
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Human medicine European public assessment report (EPAR): Kyntheum (updated)
brodalumab, Psoriasis
Date of authorisation: 17/07/2017,, Revision: 4, Authorised, Last updated: 27/07/2020
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Human medicine European public assessment report (EPAR): Alunbrig (updated)
brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018,, Revision: 3, Authorised, Last updated: 27/07/2020
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Human medicine European public assessment report (EPAR): Odefsey (updated)
emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/06/2016,, Revision: 16, Authorised, Last updated: 27/07/2020
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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: 1, Authorised, Last updated: 24/07/2020
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 16, Authorised, Last updated: 23/07/2020
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Human medicine European public assessment report (EPAR): Roteas (updated)
edoxaban tosylate, Stroke, Venous Thromboembolism
Date of authorisation: 19/04/2017,, Revision: 5, Authorised, Last updated: 23/07/2020
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Human medicine European public assessment report (EPAR): Lixiana (updated)
edoxaban tosylate, Stroke, Venous Thromboembolism
Date of authorisation: 19/06/2015,, Revision: 11, Authorised, Last updated: 23/07/2020