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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): 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