38 results
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Referral: Engerix B
hepatitis B recombinant vaccine, adsorbed, Article 30 referrals
Status: European Commission final decision, opinion/position date: 13/04/2000, EC decision date: 28/08/2000, Last updated: 28/08/2000Engerix B … Overview The active substance of Engerix B is a purified recombinant … There are two strengths of Engerix B 10 and 20 μg.The 20 μg … -
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Human medicine European public assessment report (EPAR): Fendrix
hepatitis B surface antigen, Hepatitis B, Immunization
Date of authorisation: 02/02/2005, Revision: 10, Authorised, Last updated: 24/11/2017number of years, including Engerix-B, Ambirix, Twinrix, Tritanrix-HepB … Fendrix was compared with Engerix-B (another hepatitis B vaccine … compared with a double dose of Engerix B (another hepatitis B vaccine … -
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Human medicine European public assessment report (EPAR): Twinrix Paediatric
hepatitis A virus (inactivated), hepatitis B surface antigen, Immunization, Hepatitis B, Hepatitis A
Date of authorisation: 10/02/1997, Revision: 21, Authorised, Last updated: 24/04/2020protection against hepatitis A and Engerix-B for protection against hepatitis … against hepatitis A and Engerix-B for protection against hepatitis … monovalent vaccines Havrix and Engerix B Formulation and filling … -
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Human medicine European public assessment report (EPAR): Twinrix Adult
hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B, Hepatitis A, Immunization
Date of authorisation: 19/09/1996, Revision: 21, Authorised, Last updated: 24/04/2020protection against hepatitis A and Engerix-B for protection against hepatitis … protection against hepatitis A and Engerix-B for protection against hepatitis … -
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Human medicine European public assessment report (EPAR): Heplisav B
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021,
, Authorised, Last updated: 01/03/2021
B was more effective than Engerix B (another hepatitis B vaccine … compared with 80% of those given Engerix B. People given Heplisav … with Heplisav B than with Engerix B. What are the risks associated … -
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National expert: Edwige Haelterman Brenneisen, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.01 KB | PDF
- Curriculum Vitae - 22.98 KB | PDF
the following products: Engerix-B (Hepatitis B vaccine adjuvanted … -
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National expert: María Chaparro Sánchez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 84.75 KB | PDF
- Curriculum Vitae - 67.52 KB | PDF
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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: 24, Authorised, Last updated: 25/03/2021 -
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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: 23, Authorised, Last updated: 25/03/2021 -
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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 -
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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: 32, Authorised, Last updated: 01/04/2020 -
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Human medicine European public assessment report (EPAR): HBVaxPro
hepatitis B, recombinant surface antigen, Hepatitis B, Immunization
Date of authorisation: 27/04/2001, Revision: 26, Authorised, Last updated: 28/01/2020 -
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Human medicine European public assessment report (EPAR): Ambirix
hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B, Hepatitis A, Immunization
Date of authorisation: 30/08/2002, Revision: 15, Authorised, Last updated: 24/04/2020 -
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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: 35, Authorised, Last updated: 24/03/2020 -
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Human medicine European public assessment report (EPAR): Cervarix
human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Immunization
Date of authorisation: 20/09/2007, Revision: 33, Authorised, Last updated: 23/06/2020 -
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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: 40, Authorised, Last updated: 08/01/2021 -
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Human medicine European public assessment report (EPAR): Tritanrix HepB
Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid, Hepatitis B, Tetanus, Immunization, Whooping Cough, Diphtheria
Date of authorisation: 19/07/1996, Revision: 15, Withdrawn, Last updated: 07/01/2014 -
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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 -
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Human medicine European public assessment report (EPAR): ImmunoGam
human hepatitis B immunoglobulin, Immunization, Passive, Hepatitis B
Date of authorisation: 16/03/2010, Withdrawn, Last updated: 26/01/2011 -
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Human medicine European public assessment report (EPAR): Menveo
meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization, Meningitis, Meningococcal
Date of authorisation: 15/03/2010,
Date of refusal: 17/12/2009, Revision: 29, Authorised, Last updated: 26/02/2020 -
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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 -
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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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Withdrawn application: Heplisav
date of withdrawal: 10/02/2014, Initial authorisation, Last updated: 26/05/2014another hepatitis B vaccine, Engerix-B. The main measure of effectiveness … -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021Italy Valbazen 100 mg/ml sospensione per uso orale per bovini … Sverminator 10, 100 mg/ml, sospensione orale per bovini ed ovini … Albex Gold 200 mg/ml sospensione orale per bovini Albendazole … -
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Referral: Florgane
florfenicol, Article 33
Status: European Commission final decision, opinion/position date: 06/03/2013, EC decision date: 23/05/2013, Last updated: 10/07/2013Belgium Florgane 300 mg/ml sospensione iniettabile per bovini e …