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(EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Withdrawn applications Remove Withdrawn applications filter

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

fostemsavir trometamol, HIV Infections
Date of authorisation: 04/02/2021, , Revision: 1, Authorised, Last updated: 13/04/2021
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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: 3, Authorised, Last updated: 13/04/2021
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Human medicine European public assessment report (EPAR): Erleada (updated)

apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019, , Revision: 3, Authorised, Last updated: 12/04/2021
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Human medicine European public assessment report (EPAR): Coagadex (updated)

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , , Revision: 7, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Opsumit (updated)

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 17, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , , Revision: 3, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Ogivri (updated)

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018, , , Revision: 6, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 6, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Brineura (updated)

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 5, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Doptelet (updated)

avatrombopag maleate, Thrombocytopenia
Date of authorisation: 20/06/2019, , Revision: 4, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Kymriah (updated)

tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018, , , Revision: 4, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Libtayo (updated)

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 6, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Senshio (updated)

ospemifene, Postmenopause
Date of authorisation: 14/01/2015, , Revision: 11, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Vaxchora (updated)

vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020, , Revision: 2, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , , Revision: 13, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Exviera (updated)

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , , Revision: 19, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Cresemba (updated)

isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015, , Revision: 10, Authorised, Last updated: 06/04/2021
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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: 2, Authorised, Last updated: 06/04/2021
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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: 32, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Epclusa (updated)

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , , Revision: 14, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)

6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, , Revision: 12, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Amglidia (updated)

glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018, , Revision: 4, Authorised, Last updated: 31/03/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)

adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018, , , Revision: 5, Authorised, Last updated: 30/03/2021
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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: 4, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021, , , Revision: 1, Authorised, Last updated: 30/03/2021