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632 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): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,
, Revision: 10, Authorised, Last updated: 01/12/2021
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Human medicine European public assessment report (EPAR): Skyrizi (updated)
Risankizumab, Psoriasis
Date of authorisation: 26/04/2019,
, Revision: 7, Authorised, Last updated: 01/12/2021
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Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, 
, Revision: 16, Authorised, Last updated: 01/12/2021
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Human medicine European public assessment report (EPAR): Hyrimoz (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, 
, Revision: 9, Authorised, Last updated: 01/12/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, 
, Revision: 11, Authorised, Last updated: 01/12/2021
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Human medicine European public assessment report (EPAR): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 6, Authorised, Last updated: 30/11/2021
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan (updated)
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,
, Revision: 10, Authorised, Last updated: 30/11/2021
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Human medicine European public assessment report (EPAR): Regkirona (updated)
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Authorised, Last updated: 30/11/2021
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Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, 
, Revision: 14, Authorised, Last updated: 30/11/2021
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Veterinary medicine European public assessment report (EPAR): Lydaxx (updated)
tulathromycin, Cattle; Pigs; Sheep
Date of authorisation: 18/05/2020,, Revision: 2, Authorised, Last updated: 30/11/2021
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Human medicine European public assessment report (EPAR): Ogivri (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 7, Authorised, Last updated: 30/11/2021
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Human medicine European public assessment report (EPAR): Matever (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 25, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Zyllt (updated)
clopidogrel (as hydrogen sulfate), Peripheral Vascular Diseases; Stroke; Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 28/09/2009,, Revision: 15, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 1, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Trogarzo (updated)
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 5, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Spikevax (previously 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: 16, Authorised, Last updated: 26/11/2021
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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: 15, Authorised, Last updated: 26/11/2021
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Human medicine European public assessment report (EPAR): Palforzia (updated)
defatted powder of Arachis hypogaea L., semen (peanuts), Peanut Hypersensitivity
Date of authorisation: 17/12/2020,, Revision: 2, Authorised, Last updated: 26/11/2021
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Human medicine European public assessment report (EPAR): Biktarvy (updated)
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018,, Revision: 12, Authorised, Last updated: 26/11/2021
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Human medicine European public assessment report (EPAR): Steglujan (updated)
ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018,, Revision: 8, Authorised, Last updated: 26/11/2021
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Human medicine European public assessment report (EPAR): Adempas (updated)
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014,, Revision: 11, Authorised, Last updated: 26/11/2021
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,, Revision: 3, Authorised, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , , Revision: 20, Authorised, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): GHRYVELIN (previously Macimorelin Aeterna Zentaris) (updated)
macimorelin acetate, Diagnostic Techniques, Endocrine
Date of authorisation: 11/01/2019,, Revision: 2, Authorised, Last updated: 25/11/2021