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

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

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018, , , Revision: 7, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , , , Revision: 21, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Ocrevus (updated)

ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, , Revision: 10, Authorised, Last updated: 29/03/2021
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Human medicine European public assessment report (EPAR): Axumin (updated)

Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging
Date of authorisation: 21/05/2017, , Revision: 11, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Staquis (updated)

Crisaborole, Dermatitis, Atopic
Date of authorisation: 27/03/2020, , Revision: 3, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Strensiq (updated)

asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015, , , , Revision: 14, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Lenvima (updated)

lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015, , , Revision: 15, Authorised, Last updated: 25/03/2021
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2 (updated)

inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006, , Revision: 8, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Lemtrada (updated)

alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013, , , Revision: 11, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Rizmoic (updated)

Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019, , Revision: 5, Authorised, Last updated: 24/03/2021
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Human medicine European public assessment report (EPAR): Giapreza (updated)

Angiotensin II acetate, Hypotension, Shock
Date of authorisation: 23/08/2019, , Revision: 1, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Vidaza (updated)

azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008, , Revision: 21, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Omnitrope (updated)

somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006, , Revision: 17, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Deltyba (updated)

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 15, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Nyvepria (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020, , , Revision: 1, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Dectova (updated)

Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019, , Revision: 3, Authorised, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Rekovelle (updated)

follitropin delta, Anovulation
Date of authorisation: 12/12/2016, , Revision: 2, Authorised, Last updated: 22/03/2021
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria) (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014, , Revision: 11, Authorised, Last updated: 22/03/2021
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Human medicine European public assessment report (EPAR): Givlaari

Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020, , , Revision: 1, Authorised, Last updated: 18/03/2021