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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter

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Human medicine European public assessment report (EPAR): Jyseleca (updated)

filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020, , Revision: 1, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Daurismo (updated)

Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020, , , Revision: 2, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Translarna (updated)

Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014, , , , Revision: 19, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka) (updated)

irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008, , Revision: 13, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Inhixa (updated)

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , , Revision: 18, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Cabometyx (updated)

cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016, , Revision: 11, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Aybintio (updated)

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: 3, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Ifirmacombi (updated)

irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011, , Revision: 12, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Evoltra (updated)

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 30, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 10, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Shingrix (updated)

Recombinant varicella zoster virus glycoprotein E, Herpes Zoster
Date of authorisation: 21/03/2018, , Revision: 6, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Nemdatine (updated)

memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013, , Revision: 10, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)

Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020, , , Revision: 6, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Ocrevus (updated)

ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, , Revision: 11, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Keytruda (updated)

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: 33, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan (updated)

emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016, , Revision: 8, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Lorviqua (updated)

Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019, , , Revision: 5, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 12, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): HyQvia (updated)

Human normal immunoglobulin, Immunologic Deficiency Syndromes
Date of authorisation: 16/05/2013, , Revision: 16, Authorised, Last updated: 28/04/2021
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Human medicine European public assessment report (EPAR): Hefiya (updated)

adalimumab, Hidradenitis Suppurativa, Spondylitis, Ankylosing, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis
Date of authorisation: 26/07/2018, , , Revision: 7, Authorised, Last updated: 28/04/2021
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , Revision: 6, Authorised, Last updated: 28/04/2021
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Human medicine European public assessment report (EPAR): Ozempic (updated)

semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018, , Revision: 5, Authorised, Last updated: 28/04/2021
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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: 10, Authorised, Last updated: 28/04/2021
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Human medicine European public assessment report (EPAR): Posaconazole Accord (updated)

posaconazole, Mycoses
Date of authorisation: 25/07/2019, , Revision: 2, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Rivastigmine Actavis (updated)

rivastigmine hydrogen tartrate, Dementia, Alzheimer Disease, Parkinson Disease
Date of authorisation: 16/06/2011, , Revision: 14, Authorised, Last updated: 26/04/2021