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Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,
, Revision: 3, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Xofluza (updated)
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,
, Revision: 4, Authorised, Last updated: 19/01/2023
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Human medicine European public assessment report (EPAR): Amgevita (updated)
adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
, Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,
, Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Sarclisa (updated)
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Revision: 6, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Venclyxto (updated)
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 15, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 29, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 15, Authorised, Last updated: 17/01/2023
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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: 7, Authorised, Last updated: 17/01/2023
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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: 31, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Skyrizi (updated)
Risankizumab, Psoriasis; Arthritis, Psoriatic
Date of authorisation: 26/04/2019,, Revision: 14, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , 
, Revision: 1, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Kengrexal (updated)
cangrelor, Acute Coronary Syndrome; Vascular Surgical Procedures
Date of authorisation: 23/03/2015,, Revision: 15, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Atriance (updated)
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, 
, Revision: 26, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,, , Revision: 1, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , , Revision: 23, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Apexxnar (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022,, Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Koselugo (updated)
Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021,, , , Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 11, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 5, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Idefirix (updated)
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,, , , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Trogarzo (updated)
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 7, Withdrawn, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Kesimpta (updated)
ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Hukyndra (updated)
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,, Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 12, Authorised, Last updated: 16/01/2023