182 results
-
List item
Human medicine European public assessment report (EPAR): M-M-RVaxPro (updated)
measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated), Rubella, Mumps, Immunization, Measles
Date of authorisation: 05/05/2006, Revision: 26, Authorised, Last updated: 04/12/2020 -
List item
Human medicine European public assessment report (EPAR): Nimenrix (updated)
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 20/04/2012, Revision: 31, Authorised, Last updated: 03/12/2020 -
List item
Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
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: 39, Authorised, Last updated: 27/11/2020 -
List item
Human medicine European public assessment report (EPAR): Mvabea (updated)
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,
, 
, Authorised, Last updated: 24/11/2020
-
List item
Human medicine European public assessment report (EPAR): Hexyon (updated)
diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, 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, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 22, Authorised, Last updated: 18/11/2020 -
List item
Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 6, Authorised, Last updated: 18/11/2020
-
List item
Human medicine European public assessment report (EPAR): Hexacima (updated)
diphtheria toxoid / tetanus toxoid, two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin ) / inactivated poliomyelitis virus types 1,2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein, hepatitis B surface antigen, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 21, Authorised, Last updated: 12/11/2020 -
List item
Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo
porcine circovirus vaccine (inactivated, recombinant), Pigs (for fattening)
Date of authorisation: 07/02/2018, Revision: 2, Authorised, Last updated: 30/10/2020 -
List item
Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,, 
, Revision: 6, Authorised, Last updated: 29/10/2020
-
List item
Human medicine European public assessment report (EPAR): Vepacel
Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 17/02/2012, Revision: 9, Withdrawn, Last updated: 28/10/2020 -
List item
Veterinary medicine European public assessment report (EPAR): Vaxxitek HVT+IBD
Recombinant turkey herpesvirus, strain vhvt013-69, live, Embryonated eggs, Chicken
Date of authorisation: 09/08/2002, Revision: 12, Authorised, Last updated: 21/10/2020 -
List item
Human medicine European public assessment report (EPAR): Infanrix Hexa
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: 15/10/2020 -
List item
Human medicine European public assessment report (EPAR): ProQuad
virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella, Chickenpox, Rubella, Measles, Mumps, Immunization
Date of authorisation: 05/04/2006, Revision: 27, Authorised, Last updated: 08/10/2020 -
List item
Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,, , Revision: 17, Authorised, Last updated: 07/10/2020
-
List item
Veterinary medicine European public assessment report (EPAR): Vectormune ND
cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, Chicken, Embryonated eggs
Date of authorisation: 08/09/2015, Revision: 6, Authorised, Last updated: 06/10/2020 -
List item
Human medicine European public assessment report (EPAR): Vaxelis
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus, Poliomyelitis, Tetanus, Diphtheria, Whooping Cough, Hepatitis B
Date of authorisation: 15/02/2016, Revision: 8, Authorised, Last updated: 01/10/2020 -
List item
Human medicine European public assessment report (EPAR): Ervebo
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, , Revision: 1, Authorised, Last updated: 30/09/2020
-
List item
Human medicine European public assessment report (EPAR): Shingrix
Recombinant varicella zoster virus glycoprotein E, Herpes Zoster
Date of authorisation: 21/03/2018,, Revision: 5, Authorised, Last updated: 28/09/2020
-
List item
Veterinary medicine European public assessment report (EPAR): Respiporc FLUpan H1N1
Influenza A virus/humanstrain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated, Pigs
Date of authorisation: 17/05/2017, Revision: 5, Authorised, Last updated: 18/09/2020 -
List item
Veterinary medicine European public assessment report (EPAR): Poulvac E. coli
Live aroA gene deleted Escherichia coli, type 078, strain EC34195, Chicken, Turkeys
Date of authorisation: 15/06/2012, Revision: 9, Authorised, Last updated: 16/09/2020 -
List item
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: 14/09/2020 -
List item
Veterinary medicine European public assessment report (EPAR): Vectormune FP ILT + AE
live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rFP-LT) and avian encephalomyelitis virus, strain Calnek 1143 (AE), Chicken
Date of authorisation: 24/04/2020, Revision: 1, Authorised, Last updated: 09/09/2020 -
List item
Human medicine European public assessment report (EPAR): Bexsero
outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal
Date of authorisation: 13/01/2013, Revision: 26, Authorised, Last updated: 19/08/2020 -
List item
Human medicine European public assessment report (EPAR): Fluenz Tetra
reassortant influenza virus (live attenuated) of the following four strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Bolivia/559/2013, MEDI 255962)A/Hong Kong/4801/2014 (H3N2) - like strain(A/New Caledonia/71/2014, MEDI 263122)B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977), Influenza, Human
Date of authorisation: 04/12/2013, Revision: 19, Authorised, Last updated: 06/08/2020 -
List item
Veterinary medicine European public assessment report (EPAR): Gumbohatch
live attenuated infectious bursal disease virus (IBDV), strain 1052, Chicken, Embryonated chicken eggs
Date of authorisation: 12/11/2019, Revision: 1, Authorised, Last updated: 10/07/2020