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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 … public assessment reports (EPARs) that are specially written … the general public. These 'EPAR summaries for the public' … -
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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) contribution to relative … Public Assessment Report (EPAR) contribution to relative … -
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National expert: Gualberto Gussoni, European Medicines Agency (updated)
- Declaration of interests - 41.76 KB | PDF
- Curriculum Vitae - 42.22 KB | PDF
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Veterinary medicine European public assessment report (EPAR): Nobivac Myxo-RHD (updated)
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009, Rabbits
Date of authorisation: 07/09/2011, Revision: 4, Withdrawn, Last updated: 12/09/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR). Its purpose is to explain … discussion (also part of the EPAR). What is Nobivac Myxo-RHD … -
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,
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, Revision: 6, Withdrawn, Last updated: 21/08/2023
Summary documents Adakveo : EPAR - Medicine overview PDF icon … -
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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: 47, Authorised, Last updated: 21/09/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Infanrix hexa. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Cialis (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 31, Authorised, Last updated: 20/09/2023public assessment report (EPAR). It explains how the Committee … leaflet (also part of the EPAR) or contact your doctor or … discussion (also part of the EPAR). What is Cialis? Cialis is … -
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Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063., Pigs; Cattle; Sheep
Date of authorisation: 15/07/2013,
Date of refusal: 16/05/2013, Revision: 8, Withdrawn, Last updated: 04/07/2023documents Aftovaxpur DOE : EPAR - Summary for the public … EMA/301053/2013 Generic This EPAR was last updated on 04/07/2023 … -
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Veterinary medicine European public assessment report (EPAR): Comfortis
spinosad, Dogs; Cats
Date of authorisation: 11/02/2011, Revision: 12, Withdrawn, Last updated: 26/06/2023Summary documents Comfortis : EPAR - Summary for the public … EMA/732937/2010 EMEA/V/C/002233 EPAR summary for the public Comfortis … Public Assessment Report (EPAR). Its purpose is to explain … -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
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: 40, Authorised, Last updated: 22/09/2023
COVID-19 Vaccine Moderna): EPAR - All authorised presentations … -
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS)
nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017,
, Revision: 6, Withdrawn, Last updated: 14/06/2023
Nitisinone MendeliKABS) : EPAR - Summary for the public … Public Assessment Report (EPAR) for Nitisinone MDK will … -
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Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 19, Withdrawn, Last updated: 04/08/2023Summary documents Busilvex : EPAR - Summary for the public … EMA/500878/2014 Generic This EPAR was last updated on 04/08/2023 … IAIN/0035/G Busilvex : EPAR - Product Information PDF … -
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Human medicine European public assessment report (EPAR): Tesavel (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 10/01/2008, Revision: 28, Authorised, Last updated: 19/09/2023public assessment report (EPAR) for Tesavel. It explains … leaflet (also part of the EPAR) or contact your doctor or … Summary documents Tesavel : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Imbruvica (updated)
Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014, Revision: 31, Authorised, Last updated: 22/09/2023Imbruvica : EPAR - Medicine overview (PDF/145.18 … -
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Human medicine European public assessment report (EPAR): Tenkasi (previously Orbactiv) (updated)
oritavancin (diphosphate), Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 19/03/2015, Revision: 14, Authorised, Last updated: 22/09/2023Tenkasi (previously Orbactiv) : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): Ilaris (updated)
Canakinumab, Cryopyrin-Associated Periodic Syndromes; Arthritis, Juvenile Rheumatoid; Arthritis, Gouty
Date of authorisation: 23/10/2009, Revision: 30, Authorised, Last updated: 25/08/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Ilaris. It explains … characteristics (also part of the EPAR). Ilaris can only be obtained … -
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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: 61, Authorised, Last updated: 18/09/2023information. 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): Tecfidera (updated)
dimethyl fumarate, Multiple Sclerosis
Date of authorisation: 30/01/2014, Revision: 28, Authorised, Last updated: 20/09/2023Summary documents Tecfidera : EPAR - Medicine overview PDF icon … -
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Human medicine European public assessment report (EPAR): ellaOne (updated)
ulipristal, Contraception, Postcoital
Date of authorisation: 15/05/2009, Revision: 30, Authorised, Last updated: 19/09/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for ellaOne. It explains … leaflet (also part of the EPAR) or contact your doctor or … -
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Human medicine European public assessment report (EPAR): Xelevia (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 38, Authorised, Last updated: 19/09/2023information. Abbreviated as EPAR. More information can be found … public assessment report (EPAR) for Xelevia. 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: 45, Authorised, Last updated: 18/09/2023information. 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): NeuroBloc
botulinum toxin type B, Torticollis
Date of authorisation: 22/01/2001, Revision: 33, Withdrawn, Last updated: 04/05/2023Summary documents NeuroBloc : EPAR - Summary for the public … Public Assessment Report (EPAR) for NeuroBloc (SRD) will … -
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Human medicine European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 17, Authorised, Last updated: 22/09/2023Summary documents Adcirca : EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,, Revision: 5, Authorised, Last updated: 22/09/2023
Summary documents Vaxneuvance : EPAR - Medicine overview PDF icon … EMA/804710/2022 Generic Vaxneuvance : EPAR - Risk management plan summary … 17/01/2022 12/05/2023 Generic This EPAR was last updated on 22/09/2023 … -
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Human medicine European public assessment report (EPAR): Renagel
sevelamer, Renal Dialysis; Hyperphosphatemia
Date of authorisation: 28/01/2000, Revision: 36, Authorised, Last updated: 07/08/2023information. 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 …