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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): Lamzede (updated)
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 6, 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): Yargesa (updated)
miglustat, Gaucher Disease
Date of authorisation: 22/03/2017,, Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS) (updated)
nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017,, Revision: 6, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma (updated)
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,, Revision: 3, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Thiotepa Riemser
thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms
Date of authorisation: 26/03/2021,, Revision: 3, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 9, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 16, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 5, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 14, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 15, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 12, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 8, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, , Revision: 12, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 3, Authorised, Last updated: 26/01/2023
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 20/01/2023