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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Paediatric investigation plans Remove Paediatric investigation plans filter

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Human medicine European public assessment report (EPAR): Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013, , , Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Mysimba

bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight
Date of authorisation: 26/03/2015, , Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Orkambi

Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015, , Revision: 24, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)

insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014, , Revision: 10, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , , Revision: 13, Authorised, Last updated: 11/12/2020
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Human medicine European public assessment report (EPAR): Tysabri

natalizumab, Multiple Sclerosis
Date of authorisation: 27/06/2006, , Revision: 32, Authorised, Last updated: 11/12/2020
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Human medicine European public assessment report (EPAR): Ibrance

palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016, , Revision: 11, Authorised, Last updated: 11/12/2020
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Human medicine European public assessment report (EPAR): Myalepta

Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018, , , , Revision: 5, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Kanuma

sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015, , , , Revision: 6, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Kaftrio

ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020, , , Revision: 1, Authorised, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Aybintio

bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020, , , Revision: 1, Authorised, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Alpivab

Peramivir, Influenza, Human
Date of authorisation: 13/04/2018, , Revision: 2, Withdrawn, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Zepatier

elbasvir, grazoprevir, Hepatitis C, Chronic
Date of authorisation: 22/07/2016, , Revision: 10, Authorised, Last updated: 08/12/2020
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Human medicine European public assessment report (EPAR): Neparvis

sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016, , Revision: 10, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Caprelsa

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , , Revision: 18, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Libtayo

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 5, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Onpattro

patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018, , , , Revision: 8, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Atriance

nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007, , , Revision: 24, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Remsima

infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 21, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Amsparity

adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, Hidradenitis Suppurativa
Date of authorisation: 13/02/2020, , , Revision: 1, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Eklira Genuair

aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012, , Revision: 17, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Evoltra

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 29, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Benepali

etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016, , Revision: 12, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Kevzara

sarilumab, Arthritis, Rheumatoid
Date of authorisation: 23/06/2017, , Revision: 4, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Scenesse

afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014, , , , Revision: 7, Authorised, Last updated: 30/11/2020