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Press release: EPAR summaries for the public: A further step for the provision of better information about medicines
Last updated: 02/02/2009EPAR summaries for the public … EMEA/40317/2006 PRESS RELEASE EPAR summaries for the public … public assessment reports (EPARs) that are specially written … -
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Press release: European Medicines Agency and EUnetHTA Joint Action start collaboration on European Public Assessment Report (EPAR) contribution to relative effectiveness assessments
Last updated: 16/02/2010Public Assessment Report (EPAR) contribution to relative … Public Assessment Report (EPAR) could make a better contribution … collaboration will be the EPARs, which are published by the … -
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National expert: Gualberto Gussoni, European Medicines Agency (updated)
- Declaration of interests - 80.24 KB | PDF
- Curriculum Vitae - 90.61 KB | PDF
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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: 78, Authorised, Last updated: 23/09/2020 -
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Human medicine European public assessment report (EPAR): Infanrix Hexa (updated)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type-b polysaccharide, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 23/10/2000, Revision: 42, Authorised, Last updated: 15/10/2020EMA/670868/2015 EMEA/H/C/000296 EPAR summary for the public Infanrix … public assessment report (EPAR) for Infanrix hexa. It explains … October 2000. The full EPAR for Infanrix hexa can be … -
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Human medicine European public assessment report (EPAR): Prezista (updated)
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 50, Authorised, Last updated: 13/10/2020Summary documents Prezista : EPAR - Summary for the public … EMA/413582/2020 Generic Prezista : EPAR - Risk-management-plan summary … product characteristics This EPAR was last updated on 13/10/2020 … -
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Human medicine European public assessment report (EPAR): Abilify (updated)
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 04/06/2004, Revision: 47, Authorised, Last updated: 20/10/2020EMA/807076/2016 EMEA/H/C/000471 EPAR summary for the public Abilify … public assessment report (EPAR) for Abilify. It explains … on 4 June 2004. The full EPAR for Abilify can be found … -
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Human medicine European public assessment report (EPAR): Alimta (updated)
pemetrexed, Mesothelioma, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/09/2004, Revision: 25, Authorised, Last updated: 27/10/2020Alimta EPAR Summary update for II 33 … EMA/858317/2011 EMEA/H/C/000564 EPAR summary for the public Alimta … public assessment report (EPAR) for Alimta. It explains … -
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Human medicine European public assessment report (EPAR): Vfend (updated)
voriconazole, Candidiasis, Mycoses, Aspergillosis
Date of authorisation: 19/03/2002, Revision: 47, Authorised, Last updated: 15/10/2020public assessment report (EPAR) for Vfend. It explains how … characteristics (also part of the EPAR). How has Vfend been studied … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Cancidas (previously Caspofungin MSD)
caspofungin, Candidiasis, Aspergillosis
Date of authorisation: 23/10/2001, Revision: 26, Authorised, Last updated: 22/09/2020EMA/480068/2016 EMEA/H/C/000379 EPAR summary for the public Cancidas … public assessment report (EPAR) for Cancidas. It explains … characteristics (also part of the EPAR). What benefits of Cancidas … -
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Human medicine European public assessment report (EPAR): Luminity (updated)
perflutren, Echocardiography
Date of authorisation: 20/09/2006, Revision: 14, Authorised, Last updated: 22/10/2020public assessment reports (EPARs) for each medicine: ema.europa.eu/Find … information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). It explains how the The … -
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Human medicine European public assessment report (EPAR): Keppra
levetiracetam, Epilepsy
Date of authorisation: 29/09/2000, Revision: 47, Authorised, Last updated: 25/09/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Keppra. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Cymbalta
duloxetine, Anxiety Disorders, Diabetic Neuropathies, Depressive Disorder, Major
Date of authorisation: 17/12/2004, Revision: 30, Authorised, Last updated: 25/09/2020Cymbalta duloxetine EPAR summary for the public … Public Assessment Report (EPAR). It explains how the Committee … Leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Stocrin (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 44, Authorised, Last updated: 27/10/2020EMA/778097/2017 EMEA/H/C/000250 EPAR summary for the public Stocrin … public assessment report (EPAR) for Stocrin. It explains … characteristics (also part of the EPAR). Stocrin EMA/778097/2017 … -
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Human medicine European public assessment report (EPAR): Temodal
temozolomide, Glioma, Glioblastoma
Date of authorisation: 26/01/1999, Revision: 33, Authorised, Last updated: 29/09/2020information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Temodal. It explains … characteristics (also part of the EPAR). How does Temodal work? The … -
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Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
pneumococcal polysaccharide serotype 1 / pneumococcal polysaccharide serotype 14 / pneumococcal polysaccharide serotype 18C / pneumococcal polysaccharide serotype 19A, pneumococcal polysaccharide serotype 19F / pneumococcal polysaccharide serotype 23F / 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 protein, Pneumococcal Infections, Immunization
Date of authorisation: 09/12/2009, Revision: 38, Authorised, Last updated: 05/10/2020EMA/90006/2015 EMEA/H/C/001104 EPAR summary for the public Prevenar … 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): MabThera (updated)
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 02/06/1998, Revision: 51, Authorised, Last updated: 16/10/2020MabThera : EPAR - Medicine overview (PDF/89.09 … -
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Veterinary medicine European public assessment report (EPAR): Vaxxitek HVT+IBD (updated)
Recombinant turkey herpesvirus, strain vhvt013-69, live, Embryonated eggs, Chicken
Date of authorisation: 09/08/2002, Revision: 12, Authorised, Last updated: 21/10/2020PUBLIC ASSESSMENT REPORT (EPAR) VAXXITEK HVT+IBD EPAR summary for the public … Discussion (also part of the EPAR). What is Vaxxitek HVT+IBD … information module of the EPAR. What is the time to allow … -
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Human medicine European public assessment report (EPAR): Yentreve
duloxetine hydrochloride, Urinary Incontinence, Stress
Date of authorisation: 11/08/2004, Revision: 27, Authorised, Last updated: 22/09/2020PUBLIC ASSESSMENT REPORT (EPAR) YENTREVE EPAR summary for the public … Public Assessment Report (EPAR). It explains how the Committee … Leaflet (also part of the EPAR) or contact your doctor or … -
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Veterinary medicine European public assessment report (EPAR): Mirataz
mirtazapine, Cats
Date of authorisation: 10/12/2019, Revision: 1, Authorised, Last updated: 10/07/2020 -
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Human medicine European public assessment report (EPAR): Mixtard (updated)
insulin human, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 19, Authorised, Last updated: 12/10/2020EMA/572586/2014 EMEA/H/C/000428 EPAR summary for the public Mixtard … public assessment report (EPAR) for Mixtard. It explains … October 2002. The full EPAR for Mixtard can be found … -
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Human medicine European public assessment report (EPAR): Azilect (updated)
rasagiline, Parkinson Disease
Date of authorisation: 21/02/2005, Revision: 21, Authorised, Last updated: 22/10/2020EMA/271560/2016 EMEA/H/C/000574 EPAR summary for the public Azilect … public assessment report (EPAR) for Azilect. It explains … February 2005. The full EPAR for Azilect can be found … -
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Human medicine European public assessment report (EPAR): Actrapid (updated)
human insulin, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 17, Authorised, Last updated: 21/10/2020EMA/778871/2012 EMEA/H/C/000424 EPAR summary for the public Actrapid … public assessment report (EPAR) for Actrapid. It explains … October 2002. The full EPAR for Actrapid can be found … -
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Human medicine European public assessment report (EPAR): RotaTeq
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization, Rotavirus Infections
Date of authorisation: 26/06/2006, Revision: 29, Authorised, Last updated: 14/09/2020EMA/25046/2016 EMEA/H/C/000669 EPAR summary for the public RotaTeq … public assessment report (EPAR) for RotaTeq. It explains … 27 June 2006. The full EPAR for RotaTeq can be found … -
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Human medicine European public assessment report (EPAR): Pregabalin Pfizer (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 10/04/2014, Revision: 20, Authorised, Last updated: 20/10/2020EMA/220635/2014 EMEA/H/C/003880 EPAR summary for the public Pregabalin … public assessment report (EPAR) for Pregabalin Pfizer. It … 10 April 2014. The full EPAR and risk management plan …