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1066 results
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Human medicine European public assessment report (EPAR): Hemgenix (updated)
etranacogene dezaparvovec, Hemophilia B
Date of authorisation: 20/02/2023,,
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, Authorised, Last updated: 28/02/2023
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Human medicine European public assessment report (EPAR): Temozolomide Hexal (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 27/02/2023
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Human medicine European public assessment report (EPAR): Tukysa (updated)
Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021,, Revision: 3, Authorised, Last updated: 27/02/2023
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Human medicine European public assessment report (EPAR): Veltassa (updated)
patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017,, Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Pelmeg (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,,
, Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,,
, Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,,
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, Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)
telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 11, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Fulvestrant Mylan (updated)
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 5, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Vizarsin (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 19, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Evenity (updated)
Romosozumab, Osteoporosis
Date of authorisation: 09/12/2019,, Revision: 3, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,,
, Revision: 2, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Rasagiline Mylan (updated)
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 7, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 7, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,,
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, Revision: 13, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Azacitidine Mylan (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Zalasta (updated)
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 20, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Krka (updated)
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Ilumetri (updated)
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 8, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Hyrimoz (updated)
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: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Lamzede (updated)
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,,
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, Revision: 6, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,,
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, Revision: 14, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Nimvastid (updated)
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Tolura (updated)
telmisartan, Hypertension
Date of authorisation: 04/06/2010,, Revision: 11, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Trodelvy (updated)
Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms
Date of authorisation: 22/11/2021,, Revision: 2, Authorised, Last updated: 22/02/2023