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157 results
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,
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, Revision: 9, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, 
, Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, 
, Revision: 11, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 12, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, Revision: 11, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, 
, , Revision: 4, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 23, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 3, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 6, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Hemgenix
Etranacogene dezaparvovec, Hemophilia B
Date of authorisation: 20/02/2023,, , , Revision: 1, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Aybintio
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,, , Revision: 7, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Onbevzi
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021,, , Revision: 4, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, Revision: 19, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Revision: 4, Authorised, Last updated: 05/04/2023
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 8, Authorised, Last updated: 05/04/2023
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 9, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , , Revision: 14, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 5, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Grasustek
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, , Revision: 4, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, , Revision: 25, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 5, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 8, Authorised, Last updated: 27/03/2023
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Human medicine European public assessment report (EPAR): Imraldi
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, Revision: 20, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, Revision: 10, Authorised, Last updated: 24/03/2023