European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - 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 - vaccines - active immunisation against invasive disease and acute otitis media caused by streptococcus pneumoniae in infants and children from six weeks up to five years of age. see sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes.the use of synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - 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 - vaccines - active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.active immunisation for the prevention of invasive disease caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly.see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.the use of prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

Ireland - English - HPRA (Health Products Regulatory Authority)

forte healthcare ltd - bovine coronavirus strain c-197 (inactivated); bovine rotavirus strain tm-91, serotype g6p1 (inactivated). ; escherichia coli strain ec/17, (inactivated) expressing f5(k99) adhesin - emulsion for injection - . - bovine rotavirus + bovine coronavirus + escherichia - cattle - immunological - inactivated vaccine

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - bovine rotavirus (04-1) - unknown - bovine rotavirus (04-1) biological-virus active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - bovine rotavirus (ncdv) - unknown - bovine rotavirus (ncdv) biological-virus active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - equine rotavirus (inactivated) - unknown - equine rotavirus (inactivated) biological active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - bovine rotavirus g10 - unknown - bovine rotavirus g10 active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - bovine rotavirus g6 - unknown - bovine rotavirus g6 active 0.0 - active constituent

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

kernfarm b.v. - escherichia coli (inactivated) ; escherichia coli (inactivated) ; escherichia coli (inactivated) ; escherichia coli (inactivated) ; suis rotavirus (inactivated) ; escherichia coli (inactivated) - emulsion for injection - rotavirus suis, inactivated; escherichia coli, inactivated - porcine rotavirus + escherichia - pig

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

glaxosmithkline biologicals s.a. - rotavirus humano, vivo atenuado, cepa rix4414 - rotavirus humano, vivo atenuado, cepa rix4414....no menos de 10 x 6 ccid50