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410 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma
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): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,
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, Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Ondexxya
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 13, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, 
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, 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): Spevigo
Spesolimab, Psoriasis
Date of authorisation: 09/12/2022,, , Authorised, Last updated: 08/02/2023
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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): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 15, Authorised, Last updated: 01/02/2023
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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): Tecartus
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Revision: 4, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, , Revision: 2, 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
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 18, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Oprymea
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 12/09/2008,, Revision: 22, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 1, Authorised, Last updated: 17/01/2023