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Medicine
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Human medicine European public assessment report (EPAR): Hexyon (updated)
diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 23, Authorised, Last updated: 13/01/2021 -
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Human medicine European public assessment report (EPAR): Foclivia (updated)
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,
, Revision: 10, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Fycompa (updated)
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 19, Authorised, Last updated: 13/01/2021 -
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Human medicine European public assessment report (EPAR): Stelara (updated)
Ustekinumab, Psoriasis, Arthritis, Psoriatic, Crohn Disease
Date of authorisation: 15/01/2009, Revision: 33, Authorised, Last updated: 13/01/2021 -
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Human medicine European public assessment report (EPAR): Amyvid (updated)
florbetapir (18F), Radionuclide Imaging
Date of authorisation: 14/01/2013, Revision: 13, Authorised, Last updated: 12/01/2021 -
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Human medicine European public assessment report (EPAR): Enbrel (updated)
etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid
Date of authorisation: 02/02/2000, Revision: 63, Authorised, Last updated: 12/01/2021 -
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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,
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, Revision: 1, Authorised, Last updated: 12/01/2021
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Human medicine European public assessment report (EPAR): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018,, Revision: 8, Authorised, Last updated: 11/01/2021
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Human medicine European public assessment report (EPAR): Axumin (updated)
Fluciclovine (18F), Prostatic Neoplasms, Radionuclide Imaging
Date of authorisation: 21/05/2017,, Revision: 10, Authorised, Last updated: 11/01/2021
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Human medicine European public assessment report (EPAR): Panretin (updated)
alitretinoin, Sarcoma, Kaposi
Date of authorisation: 11/10/2000, Revision: 17, Withdrawn, Last updated: 11/01/2021 -
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Human medicine European public assessment report (EPAR): Ozempic (updated)
semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018,, Revision: 4, Authorised, Last updated: 11/01/2021
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Human medicine European public assessment report (EPAR): Orfadin (updated)
nitisinone, Tyrosinemias
Date of authorisation: 20/02/2005, Revision: 19, Authorised, Last updated: 11/01/2021 -
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Human medicine European public assessment report (EPAR): BeneFIX (updated)
Nonacog alfa, Hemophilia B
Date of authorisation: 27/08/1997, Revision: 40, Authorised, Last updated: 11/01/2021 -
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Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections, Immunization
Date of authorisation: 09/12/2009, Revision: 40, Authorised, Last updated: 08/01/2021 -
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Human medicine European public assessment report (EPAR): Daurismo (updated)
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, 
, Revision: 1, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)
daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,
, Revision: 9, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Xyrem (updated)
sodium oxybate, Cataplexy, Narcolepsy
Date of authorisation: 13/10/2005, Revision: 31, Authorised, Last updated: 08/01/2021 -
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Human medicine European public assessment report (EPAR): Roteas (updated)
edoxaban tosylate, Stroke, Venous Thromboembolism
Date of authorisation: 19/04/2017,, Revision: 7, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 8, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Somavert (updated)
Pegvisomant, Acromegaly
Date of authorisation: 12/11/2002, Revision: 24, Authorised, Last updated: 07/01/2021 -
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, 
, Revision: 9, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Rapamune (updated)
Sirolimus, Graft Rejection, Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 40, Authorised, Last updated: 07/01/2021 -
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Human medicine European public assessment report (EPAR): Livogiva (updated)
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, , Revision: 1, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Rebif (updated)
interferon beta-1a, Multiple Sclerosis
Date of authorisation: 03/05/1998, Revision: 39, Authorised, Last updated: 07/01/2021 -
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 7, Authorised, Last updated: 07/01/2021