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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)
darunavir, HIV Infections
Date of authorisation: 26/01/2018,
, Revision: 6, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Ibandronic Acid Teva (updated)
ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010,, Revision: 10, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,
, Revision: 4, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,
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, , Revision: 6, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)
telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 12, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, , Revision: 4, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 11, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , , Revision: 15, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, 
, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 4, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 8, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 7, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 11, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 27, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Wakix (updated)
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 9, Authorised, Last updated: 21/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel TAD (updated)
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 12, Authorised, Last updated: 18/01/2021
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 18/01/2021
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi (updated)
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 8, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Grepid (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 21, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Zonisamide Mylan (updated)
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Krka (updated)
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 15, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 1, Authorised, Last updated: 12/01/2021