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Human medicine European public assessment report (EPAR): Juluca (updated)
dolutegravir sodium, rilpivirine hydrochloride, HIV Infections
Date of authorisation: 16/05/2018,
, Revision: 3, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Daurismo
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, 
, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, 
, , Revision: 12, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Trazimera (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018,, 
, Revision: 6, Authorised, Last updated: 09/07/2020
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 21, Authorised, Last updated: 09/07/2020
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Human medicine European public assessment report (EPAR): Trogarzo (updated)
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 2, Authorised, Last updated: 09/07/2020
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Human medicine European public assessment report (EPAR): Elocta (updated)
efmoroctocog alfa, Hemophilia A
Date of authorisation: 18/11/2015,, Revision: 9, Authorised, Last updated: 08/07/2020
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Referral: Picato (updated)
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 02/07/2020, Last updated: 08/07/2020 -
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Human medicine European public assessment report (EPAR): Picato (updated)
Ingenol mebutate, Keratosis, Actinic
Date of authorisation: 15/11/2012,
, , Revision: 9, Withdrawn, Last updated: 08/07/2020
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Human medicine European public assessment report (EPAR): Cotellic (updated)
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015,, Revision: 8, Authorised, Last updated: 07/07/2020
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Orphan designation: Osilodrostat for: Treatment of Cushing's syndrome (updated)
Date of first decision: 15/10/2014, Positive, Last updated: 07/07/2020 -
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, 
, Revision: 4, Authorised, Last updated: 07/07/2020
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 10, Authorised, Last updated: 07/07/2020
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Human medicine European public assessment report (EPAR): Tavlesse (updated)
Fostamatinib disodium, Thrombocytopenia
Date of authorisation: 09/01/2020,, Revision: 2, Authorised, Last updated: 06/07/2020
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Human medicine European public assessment report (EPAR): Intuniv (updated)
guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity
Date of authorisation: 17/09/2015,, Revision: 7, Authorised, Last updated: 06/07/2020
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Authorised, Last updated: 06/07/2020
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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: 6, Authorised, Last updated: 03/07/2020
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Human medicine European public assessment report (EPAR): Synjardy (updated)
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015,, Revision: 16, Authorised, Last updated: 03/07/2020
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Human medicine European public assessment report (EPAR): Zoely (updated)
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011,, Revision: 19, Authorised, Last updated: 03/07/2020
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, , Revision: 14, Authorised, Last updated: 03/07/2020
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 27/09/2017,, Revision: 8, Authorised, Last updated: 02/07/2020
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Human medicine European public assessment report (EPAR): Vemlidy (updated)
tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017,, Revision: 7, Authorised, Last updated: 02/07/2020
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Human medicine European public assessment report (EPAR): Kymriah (updated)
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 2, Authorised, Last updated: 29/06/2020
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Human medicine European public assessment report (EPAR): Spherox (updated)
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017,, Revision: 4, Authorised, Last updated: 29/06/2020
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 7, Authorised, Last updated: 29/06/2020