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

Medicine type Biosimilar Remove Biosimilar filter Additional monitoring Remove Additional monitoring filter Exceptional circumstances Remove Exceptional circumstances filter

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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: 21, Authorised, Last updated: 25/05/2022
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Human medicine European public assessment report (EPAR): Firdapse (previously Zenas) (updated)

amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009, , , Revision: 21, Authorised, Last updated: 25/05/2022
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Human medicine European public assessment report (EPAR): Beovu (updated)

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 5, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Elaprase (updated)

idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007, , , Revision: 23, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Rubraca (updated)

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 8, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)

teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012, , , Revision: 19, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Zessly (updated)

infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018, , , Revision: 9, Authorised, Last updated: 23/05/2022
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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: 45, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , Revision: 9, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Breyanzi (updated)

CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022, , Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Cinryze (updated)

C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011, , Revision: 22, Authorised, Last updated: 20/05/2022
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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): MenQuadfi (updated)

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020, , Revision: 6, Authorised, Last updated: 19/05/2022
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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): Mysimba (updated)

bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015, , Revision: 21, 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): PreHevbri (updated)

hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022, , 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): Padcev (updated)

Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022, , Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Alunbrig (updated)

brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018, , Revision: 8, 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): Bimzelx (updated)

bimekizumab, Psoriasis
Date of authorisation: 20/08/2021, , Revision: 1, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Dupixent (updated)

dupilumab, Dermatitis, Atopic
Date of authorisation: 26/09/2017, , Revision: 15, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Ilumetri (updated)

tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018, , Revision: 5, Authorised, Last updated: 13/05/2022