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Human medicine European public assessment report (EPAR): Puregon (updated)
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 02/05/1996, Revision: 34, Authorised, Last updated: 29/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). It explains how the The … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,
, Revision: 45, Authorised, Last updated: 29/03/2023
information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Glivec. It explains … Summary documents Glivec : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Temybric Ellipta
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 12/06/2019,, Revision: 4, Withdrawn, Last updated: 24/11/2022
documents Temybric Ellipta : EPAR - Medicine overview PDF icon … Generic Temybric Ellipta : EPAR - Risk-management-plan summary … 23/09/2019 24/11/2022 Generic This EPAR was last updated on 24/11/2022 … -
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Human medicine European public assessment report (EPAR): Ecalta (updated)
anidulafungin, Candidiasis
Date of authorisation: 20/09/2007, Revision: 24, Authorised, Last updated: 21/03/2023characteristics (also part of the EPAR). What benefits of Ecalta have … public assessment reports (EPARs) for each medicine: ema.europa.eu/Find … -
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Human medicine European public assessment report (EPAR): Erivedge (updated)
vismodegib, Carcinoma, Basal Cell
Date of authorisation: 12/07/2013,
Date of refusal: 26/04/2013, Revision: 15, Authorised, Last updated: 20/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Erivedge. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Prevenar 13
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: 43, Authorised, Last updated: 15/02/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Prevenar 13. It explains … characteristics (also part of the EPAR). How does Prevenar 13 work … -
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Human medicine European public assessment report (EPAR): Hexacima (updated)
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 28, Authorised, Last updated: 22/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Hexacima. It explains … Summary documents Hexacima : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Hexyon (updated)
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, Diphtheria toxoid, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 29, Authorised, Last updated: 22/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Hexyon. It explains … Summary documents Hexyon : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Revatio (updated)
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 49, Authorised, Last updated: 21/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Revatio. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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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; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 52, Authorised, Last updated: 28/03/2023Summary documents Opdivo : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): Xarelto
rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 30/09/2008, Revision: 39, Authorised, Last updated: 23/02/2023Summary documents Xarelto : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): HyQvia (updated)
Human normal immunoglobulin, Immunologic Deficiency Syndromes
Date of authorisation: 16/05/2013, Revision: 19, Authorised, Last updated: 30/03/2023public assessment report (EPAR) for HyQvia. It explains … leaflet (also part of the EPAR) or contact your doctor or … Summary documents HyQvia : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, Revision: 16, Authorised, Last updated: 22/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Ocrevus. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Lyrica (updated)
pregabalin, Epilepsy; Anxiety Disorders; Neuralgia
Date of authorisation: 05/07/2004, Revision: 59, Authorised, Last updated: 17/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Lyrica. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Rasilez
aliskiren, Hypertension
Date of authorisation: 22/08/2007, Revision: 27, Authorised, Last updated: 23/02/2023public assessment report (EPAR) for Rasilez. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Viagra (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 13/09/1998, Revision: 44, Authorised, Last updated: 17/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Viagra. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): CellCept (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 14/02/1996, Revision: 38, Authorised, Last updated: 17/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). It explains how the The … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Circadin (updated)
melatonin, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/06/2007, Revision: 33, Authorised, Last updated: 09/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). It explains how the The … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Zinplava (updated)
bezlotoxumab, Enterocolitis, Pseudomembranous
Date of authorisation: 18/01/2017, Revision: 9, Authorised, Last updated: 14/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Zinplava. It explains … EMA/201086/2017 EMEA/H/C/004136 EPAR summary for the public Zinplava … -
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Human medicine European public assessment report (EPAR): Taltz
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016, Revision: 17, Authorised, Last updated: 22/02/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Taltz. It explains how … characteristics (also part of the EPAR). How does Taltz work? The … -
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Human medicine European public assessment report (EPAR): Azopt (updated)
brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 28, Authorised, Last updated: 29/03/2023public assessment report (EPAR) for Azopt. It explains how … leaflet (also part of the EPAR) or contact your doctor or … Summary documents Azopt : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Repatha
Evolocumab, Dyslipidemias; Hypercholesterolemia
Date of authorisation: 17/07/2015, Revision: 23, Authorised, Last updated: 23/01/2023Repatha : EPAR - All Authorised presentations … -
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Human medicine European public assessment report (EPAR): Humira
adalimumab, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 08/09/2003, Revision: 89, Authorised, Last updated: 16/12/2022Humira : EPAR - All Authorised presentations … -
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Human medicine European public assessment report (EPAR): Herceptin (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 42, Authorised, Last updated: 17/03/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Herceptin. It explains … EMA/981900/2011 EMEA/H/C/000278 EPAR summary for the public Herceptin … -
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Human medicine European public assessment report (EPAR): Synflorix
Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal Infections; Immunization
Date of authorisation: 29/03/2009, Revision: 35, Authorised, Last updated: 30/01/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Synflorix. It explains … EMA/746787/2017 EMEA/H/C/000973 EPAR summary for the public …