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Medicine
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Human medicine European public assessment report (EPAR): Imjudo (updated)
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 15/12/2022,, Authorised, Last updated: 02/03/2023
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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: 2, Authorised, Last updated: 02/03/2023
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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: 25, Authorised, Last updated: 02/03/2023
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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: 8, Authorised, Last updated: 01/03/2023
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Human medicine European public assessment report (EPAR): Spravato (updated)
esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019,, Revision: 7, Authorised, Last updated: 01/03/2023
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Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,,
, Revision: 21, Authorised, Last updated: 01/03/2023
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Human medicine European public assessment report (EPAR): Cibinqo (updated)
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,,
, Revision: 3, Authorised, Last updated: 28/02/2023
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Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,,
, Revision: 17, Authorised, Last updated: 28/02/2023
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,,
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, Revision: 10, Authorised, Last updated: 28/02/2023
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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): 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)
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): Evenity
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
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): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
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): Ilumetri
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
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
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
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): Trodelvy
Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms
Date of authorisation: 22/11/2021,, Revision: 2, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Verzenios
abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018,, Revision: 9, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)
CX-024414 (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: 35, Authorised, Last updated: 21/02/2023