18245 results
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms
Date of authorisation: 19/06/2015, Revision: 38, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,
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, Revision: 7, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 16, Authorised, Last updated: 06/05/2021
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COVID-19: latest updates (updated)
Last updated: 06/05/2021 -
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Article 5(3) opinions (updated)
Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Latuda (updated)
lurasidone, Schizophrenia
Date of authorisation: 21/03/2014, Revision: 23, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Aldara (updated)
imiquimod, Condylomata Acuminata, Keratosis, Keratosis, Actinic, Carcinoma, Basal Cell
Date of authorisation: 18/09/1998, Revision: 28, Authorised, Last updated: 06/05/2021 -
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Veterinary medicine European public assessment report (EPAR): Prevexxion RN (updated)
Live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250, Chicken
Date of authorisation: 20/07/2020, Revision: 1, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Humira (updated)
adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 08/09/2003, Revision: 82, Authorised, Last updated: 06/05/2021 -
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Brazil (updated)
Last updated: 06/05/2021 -
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Veterinary medicine European public assessment report (EPAR): Librela (new)
bedinvetmab, Dogs
Date of authorisation: 10/11/2020, Authorised, Last updated: 06/05/2021 -
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News: Confidentiality arrangement between EU and Brazilian regulatory authorities (new)
Last updated: 06/05/2021 -
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Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor for: Treatment of cystic fibrosis (updated)
Date of first decision: 14/12/2018, Positive, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 3, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Aflunov (updated)
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 28/11/2010, Revision: 13, Authorised, Last updated: 06/05/2021 -
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Substance and product data management services (updated)
Last updated: 06/05/2021 -
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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: 17, Authorised, Last updated: 06/05/2021
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Orphan designation: Teicoplanin for: Treatment of cystic fibrosis (updated)
Date of first decision: 23/08/2017, Positive, Last updated: 06/05/2021 -
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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: 8, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Hepsera (updated)
adefovir dipivoxil, Hepatitis B, Chronic
Date of authorisation: 06/03/2003, Revision: 27, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Bortezomib Hospira (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,
, Revision: 11, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,, Revision: 1, Authorised, Last updated: 05/05/2021
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News: Becoming a member of one of EMA’s scientific advisory groups (new)
Last updated: 05/05/2021 -
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CHMP: Working parties and other groups (updated)
Last updated: 05/05/2021 -
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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: 2, Authorised, Last updated: 05/05/2021