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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 25, Authorised, Last updated: 06/07/2022
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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: 22, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Sovaldi (updated)

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 25, Authorised, Last updated: 06/07/2022
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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: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Alymsys (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 3, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Sogroya (updated)

Somapacitan, Growth
Date of authorisation: 31/03/2021, , , Revision: 1, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Nerlynx (updated)

neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018, , Revision: 11, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Trelegy Ellipta (updated)

fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017, , Revision: 8, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Zavicefta (updated)

avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016, , Revision: 14, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Ilumetri (updated)

tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018, , Revision: 6, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)

SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021, , , Revision: 3, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Oyavas (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: 26/03/2021, , , Revision: 3, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Senshio (updated)

ospemifene, Postmenopause
Date of authorisation: 14/01/2015, , Revision: 12, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Mysimba (updated)

bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015, , Revision: 22, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Benlysta (updated)

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 28, Authorised, Last updated: 04/07/2022
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Human medicine European public assessment report (EPAR): Filsuvez (updated)

dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022, , Authorised, Last updated: 04/07/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)

SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022, , Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Rydapt (updated)

Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017, , Revision: 8, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Xermelo (updated)

telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017, , Revision: 13, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Caprelsa (updated)

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , , Revision: 22, Authorised, Last updated: 30/06/2022
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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: 18, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 13, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Keytruda (updated)

Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015, , Revision: 46, Authorised, Last updated: 29/06/2022
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Human medicine European public assessment report (EPAR): Spikevax (previously 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: 24, Authorised, Last updated: 29/06/2022
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Human medicine European public assessment report (EPAR): Opsumit (updated)

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 20, Authorised, Last updated: 29/06/2022