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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Krka (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Tecvayli (updated)
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,,
, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, Revision: 13, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, Revision: 11, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Efavirenz Teva (updated)
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,,
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, Revision: 5, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 21, 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): 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): 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): 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)
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
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
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
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023