125 results
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Human medicine European public assessment report (EPAR): Hexacima
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: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Hexyon
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: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Champix
varenicline, Tobacco Use Cessation
Date of authorisation: 25/09/2006, Revision: 37, Authorised, Last updated: 18/10/2021 -
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Human medicine European public assessment report (EPAR): Omidria
ketorolac, phenylephrine, Lens Implantation, Intraocular; Pain, Postoperative
Date of authorisation: 28/07/2015, Revision: 7, Authorised, Last updated: 09/03/2023 -
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Human medicine European public assessment report (EPAR): Cancidas (previously Caspofungin MSD)
caspofungin (as acetate), Candidiasis; Aspergillosis
Date of authorisation: 23/10/2001, Revision: 30, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Bosulif (updated)
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013, Revision: 24, Authorised, Last updated: 17/05/2023 -
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Human medicine European public assessment report (EPAR): Elebrato Ellipta
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017, Revision: 11, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Trelegy Ellipta
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017, Revision: 10, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,
, Revision: 16, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira)
voriconazole, Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
Date of authorisation: 27/05/2015,, Revision: 11, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Gamifant
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,
, Refused, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,
, , Revision: 3, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Mimpara
cinacalcet hydrochloride, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Date of authorisation: 22/10/2004, Revision: 25, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Rotarix
human rotavirus, live attenuated, Immunization; Rotavirus Infections
Date of authorisation: 21/02/2006, Revision: 40, Authorised, Last updated: 29/06/2022 -
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Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,
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, Revision: 15, Authorised, Last updated: 01/02/2023
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Human medicine European public assessment report (EPAR): Kineret
anakinra, Arthritis, Rheumatoid; COVID-19 virus infection
Date of authorisation: 08/03/2002, Revision: 33, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Jayempi
azathioprine, Graft Rejection
Date of authorisation: 21/06/2021, Revision: 1, Authorised, Last updated: 04/03/2022 -
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Human medicine European public assessment report (EPAR): Quintanrix
Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Diphtheria
Date of authorisation: 17/02/2005, Revision: 2, Withdrawn, Last updated: 10/09/2008 -
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Human medicine European public assessment report (EPAR): Prevenar
pneumococcal oligosaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal Infections; Immunization
Date of authorisation: 02/02/2001, Revision: 23, Withdrawn, Last updated: 24/11/2017 -
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National expert: Cristina Pezzella, Italian Medicines Agency (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 53.36 KB | PDF
immunochemistry of streptococcal capsular structures, mechanism of … -
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Human medicine European public assessment report (EPAR): Eylea
aflibercept, Wet Macular Degeneration; Macular Edema; Diabetes Complications
Date of authorisation: 21/11/2012, Revision: 28, Authorised, Last updated: 10/02/2023 -
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Human medicine European public assessment report (EPAR): Relvar Ellipta
fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 13/11/2013, Revision: 24, Authorised, Last updated: 02/02/2023 -
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Veterinary medicine European public assessment report (EPAR): Startvac
Escherichia coli J5 inactivated, Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex, Cattle (cows and heifers)
Date of authorisation: 11/02/2009, Revision: 3, Authorised, Last updated: 07/05/2018 -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 26, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Comirnaty
Single-stranded, 5’-capped messenger RNA 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: 21/12/2020,
, , Revision: 41, Authorised, Last updated: 24/03/2023