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1083 results
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Human medicine European public assessment report (EPAR): MenQuadfi (updated)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,
, Revision: 6, Authorised, Last updated: 19/05/2022
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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: 11, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Apixaban Accord (updated)
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,
, Revision: 2, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 10, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 21, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Uplizna (updated)
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,, Authorised, Last updated: 19/05/2022
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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: 11, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): PreHevbri (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022,, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , Revision: 4, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Padcev (updated)
Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022,, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Alunbrig (updated)
brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018,, Revision: 8, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 8, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015,, Revision: 44, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Bimzelx (updated)
bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Revision: 1, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 7, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide ratiopharm (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 28/11/2010,, Revision: 16, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide medac (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 16, Authorised, Last updated: 16/05/2022
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Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 5, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 3, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 26/09/2017,, Revision: 15, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Ilumetri (updated)
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 5, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Zytiga (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 24, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 33, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, 
, Revision: 16, Authorised, Last updated: 12/05/2022
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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: 22, Authorised, Last updated: 12/05/2022