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Human medicine European public assessment report (EPAR): Erleada (updated)
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Imbruvica (updated)
Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014, Revision: 31, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 11, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 06/01/2021,,
, Revision: 40, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, Revision: 5, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Tezspire (updated)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 7, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,,
, Revision: 3, Authorised, Last updated: 22/09/2023
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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: 9, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,,
, Revision: 12, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Vantobra (previously Tobramycin PARI) (updated)
Tobramycin, Respiratory Tract Infections; Cystic Fibrosis
Date of authorisation: 18/02/2019, Revision: 5, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): LysaKare (updated)
L-arginine hydrochloride, L-lysine hydrochloride, Radiation Injuries
Date of authorisation: 25/07/2019, Revision: 4, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,,
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, Revision: 27, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Opfolda (updated)
miglustat, Glycogen Storage Disease Type II
Date of authorisation: 26/06/2023, Revision: 1, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Scemblix (updated)
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,,
, Revision: 3, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 19, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,, Revision: 5, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Imjudo (updated)
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 20/02/2023,, Revision: 2, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 17, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Procysbi (updated)
mercaptamine bitartrate, Cystinosis
Date of authorisation: 05/09/2013, Revision: 16, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Retsevmo (updated)
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,,
, Revision: 8, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Prolia (updated)
denosumab, Bone Resorption; Osteoporosis, Postmenopausal
Date of authorisation: 26/05/2010, Revision: 27, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Fortacin (updated)
lidocaine, prilocaine, Sexual Dysfunction, Physiological
Date of authorisation: 15/11/2013, Revision: 12, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,,
, Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, Revision: 9, Authorised, Last updated: 22/09/2023