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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Summaries of opinion Remove Summaries of opinion filter Referrals Remove Referrals filter Withdrawn applications Remove Withdrawn applications filter

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Medicine type Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Additional monitoring Remove Additional monitoring filter Biosimilar Remove Biosimilar filter

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Human medicine European public assessment report (EPAR): Polivy

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 2, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Olumiant

baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017, , Revision: 8, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Xeljanz

tofacitinib citrate, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
Date of refusal: 25/04/2013, , , Revision: 15, Authorised, Last updated: 14/12/2020
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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): 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