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Medicine
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Human medicine European public assessment report (EPAR): Strimvelis (updated)
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,
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, Revision: 5, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,
, , Revision: 18, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 1, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma (updated)
telmisartan, Hypertension
Date of authorisation: 03/10/2011,
, Revision: 9, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 8, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Javlor (updated)
vinflunine, Carcinoma, Transitional Cell, Urologic Neoplasms
Date of authorisation: 21/09/2009, Revision: 9, Authorised, Last updated: 28/01/2021 -
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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): Zubsolv (updated)
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 5, Authorised, Last updated: 27/01/2021 -
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Human medicine European public assessment report (EPAR): Bonviva (updated)
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 27, 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,, , , Revision: 6, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Jylamvo (updated)
Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis
Date of authorisation: 29/03/2017, Revision: 7, 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): Zostavax (updated)
varicella-zoster virus (live, attenuated), Herpes Zoster, Immunization
Date of authorisation: 19/05/2006, Revision: 29, Authorised, Last updated: 27/01/2021 -
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Human medicine European public assessment report (EPAR): Alunbrig (updated)
brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018,, Revision: 5, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, 
, Revision: 13, 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): Vantavo (previously Alendronate sodium and colecalciferol, MSD) (updated)
alendronic acid, colecalciferol, Osteoporosis, Postmenopausal
Date of authorisation: 16/10/2009, Revision: 15, 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): Invanz (updated)
ertapenem sodium, Community-Acquired Infections, Streptococcal Infections, Staphylococcal Infections, Gram-Negative Bacterial Infections, Surgical Wound Infection, Pneumonia, Bacterial
Date of authorisation: 18/04/2002, Revision: 23, Authorised, Last updated: 26/01/2021 -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 12, 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