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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter

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Medicine type Accelerated assessment Remove Accelerated assessment filter Generic Remove Generic filter Conditional approval Remove Conditional approval filter Additional monitoring Remove Additional monitoring filter

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Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)

telmisartan, Hypertension
Date of authorisation: 29/09/2010, , Revision: 10, Authorised, Last updated: 05/01/2021
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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: 8, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 16, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

Upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , Revision: 2, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Ontruzant (updated)

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017, , , Revision: 7, Authorised, Last updated: 04/01/2021
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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
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)

clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009, , Revision: 15, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Alofisel (updated)

darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018, , , Revision: 6, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , , Revision: 4, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Hemlibra (updated)

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , , Revision: 7, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Anoro Ellipta (previously Anoro) (updated)

umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014, , Revision: 15, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Zytiga

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011, , Revision: 23, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Keytruda

Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015, , Revision: 30, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Sixmo

Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019, , Revision: 2, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Rybelsus

semaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2020, , Revision: 2, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Laventair Ellipta (previously Laventair)

umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014, , Revision: 14, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Mylotarg

gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018, , , Revision: 7, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Quofenix

delafloxacin meglumine, Skin Diseases, Bacterial
Date of authorisation: 16/12/2019, , Revision: 2, Authorised, Last updated: 21/12/2020
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Human medicine European public assessment report (EPAR): Gilenya

fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011, , , Revision: 27, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Adcetris

Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012, , , , Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Biktarvy

bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, , Revision: 10, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Idacio

adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019, , , Revision: 5, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene)

Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013, , , Revision: 17, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Erleada

apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019, , Revision: 2, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Isturisa

Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020, , , Revision: 3, Authorised, Last updated: 17/12/2020