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Human medicine European public assessment report (EPAR): Sugammadex Adroiq
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 26/05/2023, Revision: 1, Authorised, Last updated: 12/10/2023 -
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Human medicine European public assessment report (EPAR): Hyftor
Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023,
, Revision: 2, Authorised, Last updated: 25/09/2023
used to treat benign (non-cancerous) skin tumours on the face … used to treat benign (non-cancerous) skin tumours on the face … -
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Human medicine European public assessment report (EPAR): Akeega
abiraterone acetate, Niraparib tosilate monohydrate, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 19/04/2023, Authorised, Last updated: 02/06/2023Akeega Neoplasms Cancer Urogenital Neoplasms Genital … Akeega is a cancer medicine for treating adult … castration-resistant prostate cancer that has spread to other … -
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Human medicine European public assessment report (EPAR): Pedmarqsi
Sodium thiosulfate, Ear Diseases; Ototoxicity
Date of authorisation: 26/05/2023, Revision: 1, Authorised, Last updated: 25/10/2023hearing loss caused by the cancer medicine cisplatin when used … children with hepatoblastoma (a cancer of the liver), with an average … years with different types of cancer, including hepatoblastoma … -
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Human medicine European public assessment report (EPAR): Vafseo
Vadadustat, Renal Insufficiency, Chronic; Anemia
Date of authorisation: 24/04/2023,
, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Briumvi
Ublituximab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 31/05/2023,, Revision: 01, Authorised, Last updated: 18/10/2023
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Human medicine European public assessment report (EPAR): Ztalmy
Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023,, , Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Sugammadex Piramal
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 23/06/2023,
, Authorised, Last updated: 18/07/2023
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Human medicine European public assessment report (EPAR): Jaypirca (updated)
pirtobrutinib, Lymphoma, Mantle-Cell
Date of authorisation: 30/10/2023,, 
, Authorised, Last updated: 20/11/2023
Non-Hodgkin Lymphoma Neoplasms Cancer Lymphoproliferative Disorders Lymphatic … pirtobrutinib Overview Jaypirca is a cancer medicine used to treat adults … with mantle cell lymphoma (a cancer of B cells, a type of white … -
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Human medicine European public assessment report (EPAR): Tibsovo
Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma
Date of authorisation: 04/05/2023,, , Authorised, Last updated: 12/05/2023
Tibsovo Cancer Adenocarcinoma Neoplasms … ivosidenib Overview Tibsovo is a cancer medicine used to treat adults … with azacitidine (another cancer medicine). The medicine can … -
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Human medicine European public assessment report (EPAR): Bimervax
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,, Revision: 2, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Epysqli
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,, 
, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Omvoh
Mirikizumab, Colitis, Ulcerative
Date of authorisation: 26/05/2023,, Revision: 1, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Orkambi
Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 19/11/2015, Revision: 32, Authorised, Last updated: 27/07/2023 -
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Human medicine European public assessment report (EPAR): Opzelura
ruxolitinib phosphate, Vitiligo
Date of authorisation: 19/04/2023, Revision: 1, Authorised, Last updated: 22/06/2023 -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Accord
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 15/02/2023,, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Bekemv
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 19/04/2023,, Revision: 1, Authorised, Last updated: 06/07/2023
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Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,, , Revision: 1, Authorised, Last updated: 07/08/2023
multiple myeloma (types of blood cancer); children from 1 year of age … has experience in treating cancer or blood disorders. After … multiple myeloma (types of blood cancer); • children from 1 year … -
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Human medicine European public assessment report (EPAR): Tolvaptan Accord
Tolvaptan, Inappropriate ADH Syndrome, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Sotyktu
Deucravacitinib, Psoriasis
Date of authorisation: 24/03/2023,, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Sun
sitagliptin fumarate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 31/03/2023,, Authorised, Last updated: 24/01/2023
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Human medicine European public assessment report (EPAR): Dapagliflozin Viatris
dapagliflozin, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 24/03/2023,, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord
Dabigatran etexilate mesilate, Venous Thromboembolism; Arthroplasty, Replacement
Date of authorisation: 26/05/2023,, Authorised, Last updated: 31/05/2023