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645 results
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Human medicine European public assessment report (EPAR): Efmody (updated)
hydrocortisone, Adrenal Hyperplasia, Congenital
Date of authorisation: 27/05/2021,
, Authorised, Last updated: 14/06/2021
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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,, 
, Revision: 5, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 12, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Skyrizi (updated)
Risankizumab, Psoriasis
Date of authorisation: 26/04/2019,, Revision: 5, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, 
, Revision: 13, Authorised, Last updated: 11/06/2021
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Veterinary medicine European public assessment report (EPAR): Tulissin (updated)
tulathromycin, Cattle, Pigs, Sheep
Date of authorisation: 24/04/2020,
, Revision: 2, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Xerava (updated)
eravacycline, Infection, Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 2, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm (updated)
clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke
Date of authorisation: 18/02/2015,, Revision: 11, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 22, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Zalasta (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 18, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Erelzi (updated)
etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, 
, Revision: 9, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 17, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 26, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Zoely (updated)
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011,, Revision: 20, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018,, , Revision: 6, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Talzenna (updated)
talazoparib, Breast Neoplasms
Date of authorisation: 20/06/2019,, Revision: 4, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira) (updated)
voriconazole, Bacterial Infections and Mycoses, Aspergillosis, Candidiasis
Date of authorisation: 27/05/2015,, Revision: 9, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 4, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 11, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders, Primary Myelofibrosis
Date of authorisation: 08/02/2021,, , Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Ibrance (updated)
palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 12, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Xeljanz (updated)
tofacitinib citrate, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
Date of refusal: 25/04/2013,
, , Revision: 18, Authorised, Last updated: 08/06/2021
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 35, Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, 
, , Revision: 10, Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Nexpovio (updated)
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, , Authorised, Last updated: 07/06/2021