European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, hepatitis b surface antigen, bordetella pertussis (inactivated), tetanus toxoid - hepatitis b; tetanus; immunization; whooping cough; diphtheria - vaccines - tritanrix hepb is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis b (hbv) in infants from six weeks onwards (see section 4.2).

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 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - pneumococcal infections - vaccines - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older.see sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.apexxnar should be used in accordance with official recommendations.  

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - streptococcus pneumoniae capsular polysaccharide protein conjugate - suspension for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - pneumococcal polysaccharide serotype 14 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 18c 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19f 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 23f 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 4 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6b 4ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 9v 2ug (conjugated with diphtheria crm 197 protein) - suspension for injection - 0.5 ml - active: pneumococcal polysaccharide serotype 14 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 18c 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19f 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 23f 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 4 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6b 4ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 9v 2ug (conjugated with diphtheria crm 197 protein) excipient: aluminium phosphate sodium chloride water for injection

Australia - English - Department of Health (Therapeutic Goods Administration)

tetanus toxoid; diphtheria toxoid; polyribose ribitol phosphate - haemophilus influenzae type b; poliovirus; pertactin; pertussis toxoid; hepatitis b surface antigen recombinant; pertussis filamentous haemagglutinin -

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - meningococcal oligosaccharide - group c 10ug (conjugated with 5 mcg diphtheria crm 197 protein);   - suspension for injection - 0.5 ml - active: meningococcal oligosaccharide - group c 10ug (conjugated with 5 mcg diphtheria crm 197 protein)   excipient: aluminium phosphate sodium chloride water for injection - active immunisation of children from 6 weeks of age, adolescents and adults for the prevention of invasive disease caused by neisseria meningitidis serogroup c.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - neisseria meningitidis group c polysaccharide 10ug (polysaccharide antigen from strain c11, conjugated to tetanus toxoid) - suspension for injection - 10 mcg/0.5ml - active: neisseria meningitidis group c polysaccharide 10ug (polysaccharide antigen from strain c11, conjugated to tetanus toxoid) excipient: aluminium hydroxide sodium chloride tetanus toxoid water for injection - active immunisation of children from 8 weeks of age, adolescents and adults for the prevention of invasive disease caused by neisseria meningitidis serogroup c.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - pneumococcal polysaccharide serotype 1 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 14 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 18c 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19a 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 23f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 3 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 4 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 5 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6a 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6b 4.4ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 7f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 9v 2.2ug (conjugated with diphtheria crm 197 protein) - suspension for injection - 0.5 ml - active: pneumococcal polysaccharide serotype 1 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 14 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 18c 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19a 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 23f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 3 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 4 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 5 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6a 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6b 4.4ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 7f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 9v 2.2ug (conjugated with diphtheria crm 197 protein) excipient: aluminium phosphate polysorbate 80 sodium chloride succinic acid water for injection - active immunisation for the prevention of pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f and 23f in adults and children aged more than 6 weeks of age. the use of prevenar 13 should be guided by official recommendations.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis a vaccine 50 u/ml - suspension for injection - 50 u/ml - active: hepatitis a vaccine 50 u/ml excipient: aluminium as amorphous aluminium hydroxyphosphate sulphate borax sodium chloride water for injection - vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis a virus. primary immunisation should be given at least 2 weeks prior to expected exposure to hav. vaccination is recommended in children 12 months of age and older, adolescents, and adults who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected, including but not limited to: · travellers to endemic or outbreak areas · frequently affected communities - members residing in any community with one or more recorded outbreaks within the last five years · daycare - children and staff of daycare centres as well as their parents, siblings, and other contacts · military personnel prior to departure for endemic or outbreak areas · persons for whom hepatitis a is an occupational hazard - health-care workers - staff and residents of orphanages, chronic care hospitals and mental health care facilities - sewage workers · haemophiliacs and other recipients of therapeutic blood products · persons who test positive for hepatitis c virus and have diagnosed liver disease · food handlers · consumers of high-risk foods e.g. raw shellfish · persons at increased risk of the disease due to their sexual practices - homosexually-active males - persons who repeatedly contract sexually transmitted diseases · human immunodeficiency virus (hiv)-infected adults · users of illicit injectable drugs vaqta will not prevent hepatitis caused by infectious agents other than hepatitis a virus.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); haemophilus b; hepatitis b vaccines; pertactin; pertussis toxoid (pt); poliovirus type 1 inactivated; poliovirus type 2 inactivated; poliovirus type 3 inactivated; tetanus toxoid - powder and suspension for suspension for injection - filamentous haemagglutinin (fha) 25 mcg/dose; diphtheria toxoid nlt 30 iu/dose; tetanus toxoid nlt 40 iu/dose; hepatitis b vaccines 10 mcg/dose; poliovirus type 1 inactivated 40 du/dose; poliovirus type 2 inactivated 8 du/dose; poliovirus type 3 inactivated 32 du/dose; haemophilus b 10 mcg/dose; pertactin 8 mcg/dose; pertussis toxoid (pt) 25 mcg/dose - bacterial and viral vaccines, combined - infantix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenza type b for infants between 6 weeks and 36 months of age.