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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): Jakavi (updated)
ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Date of authorisation: 23/08/2012, Revision: 26, 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): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 24, 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): Selincro (updated)
Nalmefene hydrochloride dihydrate, Alcohol-Related Disorders
Date of authorisation: 24/02/2013, Revision: 13, Authorised, Last updated: 17/05/2022 -
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 28, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Lumigan (updated)
bimatoprost, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 08/03/2002, Revision: 36, 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): Leflunomide Zentiva (previously Leflunomide Winthrop) (updated)
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 08/01/2010, Revision: 18, 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): Vimpat (updated)
lacosamide, Epilepsy
Date of authorisation: 29/08/2008, Revision: 39, Authorised, Last updated: 17/05/2022 -
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Human medicine European public assessment report (EPAR): Cosentyx (updated)
Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Date of authorisation: 14/01/2015, Revision: 26, Authorised, Last updated: 17/05/2022 -
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Human medicine European public assessment report (EPAR): Gardasil 9 (updated)
human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata; Papillomavirus Infections; Immunization; Uterine Cervical Dysplasia
Date of authorisation: 10/06/2015, Revision: 18, Authorised, Last updated: 16/05/2022