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Human medicine European public assessment report (EPAR): Sapropterin Dipharma
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,
, Revision: 2, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 13, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm
clopidogrel (as hydrogen sulfate), Myocardial Infarction; Acute Coronary Syndrome; Peripheral Vascular Diseases; Stroke
Date of authorisation: 18/02/2015,, Revision: 14, Authorised, Last updated: 15/11/2022
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Human medicine European public assessment report (EPAR): Iasibon
ibandronic acid, Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
Date of authorisation: 21/01/2011,, Revision: 11, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Teriflunomide Accord
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,
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, Revision: 33, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Miglustat Dipharma
miglustat, Gaucher Disease
Date of authorisation: 18/02/2019,, Revision: 4, Authorised, Last updated: 11/11/2022
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 26, Authorised, Last updated: 10/11/2022
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,
, , , Revision: 12, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 12, Authorised, Last updated: 04/11/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 9, Authorised, Last updated: 03/11/2022
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Human medicine European public assessment report (EPAR): Sitagliptin SUN
sitagliptin fumarate, Diabetes Mellitus, Type 2
Date of authorisation: 09/12/2021,, Revision: 1, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 24/10/2022
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 34, Authorised, Last updated: 21/10/2022
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , Revision: 24, Authorised, Last updated: 21/10/2022
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Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, Revision: 19, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 42, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Rasagiline Mylan
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 6, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2012,, Revision: 8, Withdrawn, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 9, Authorised, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 13, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET)
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022,, Revision: 2, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Olanzapine Apotex
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 10/06/2010,, Revision: 12, Authorised, Last updated: 07/10/2022
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,, , 
, Revision: 2, Authorised, Last updated: 05/10/2022
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,, , Revision: 1, Authorised, Last updated: 05/10/2022