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

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

gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019, , , Revision: 3, Authorised, Last updated: 20/05/2022
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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: 11, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Uplizna (updated)

Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022, , Authorised, Last updated: 19/05/2022
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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): Ayvakyt (updated)

avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020, , , Revision: 4, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Cometriq (updated)

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , Revision: 24, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Remsima (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 28, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)

Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011, , Revision: 19, Authorised, Last updated: 13/05/2022
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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): Imraldi (updated)

adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017, , , Revision: 16, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): SomaKit TOC (updated)

edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016, , Revision: 11, 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): Inflectra (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 29, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Galafold (updated)

migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 15, 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): Nexavar (updated)

sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 19/07/2006, , Revision: 30, 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): Lutathera (updated)

lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017, , , Revision: 6, Authorised, Last updated: 10/05/2022
List item

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

Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014, , , Revision: 13, 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