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

idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007, , , Revision: 22, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Ondexxya (updated)

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 11, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Zytiga (updated)

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011, , Revision: 24, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , , Revision: 33, Authorised, Last updated: 12/05/2022
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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: 22, Authorised, Last updated: 12/05/2022
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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: 25, Authorised, Last updated: 12/05/2022
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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: 20, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021, , , , Revision: 19, Authorised, Last updated: 12/05/2022
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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: 2, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Iclusig (updated)

ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013, , , Revision: 23, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Naglazyme (updated)

galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006, , , Revision: 19, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Hemlibra (updated)

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , , Revision: 10, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Vidaza (updated)

azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008, , Revision: 24, Authorised, Last updated: 03/05/2022
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Human medicine European public assessment report (EPAR): Paxlovid (updated)

(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022, , Revision: 1, Authorised, Last updated: 29/04/2022
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Human medicine European public assessment report (EPAR): Hepcludex (updated)

Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020, , , , Revision: 6, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)

influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009, , Revision: 7, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Ofev (updated)

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 22, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 4, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Maviret

glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , , Revision: 15, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013, , , Revision: 20, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Vosevi

Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , , Revision: 11, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Minjuvi

Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021, , , , Revision: 3, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Tagrisso

osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016, , Revision: 15, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Abecma

idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021, , , , Revision: 4, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Obizur

susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015, , , Revision: 9, Authorised, Last updated: 07/04/2022