European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - vaccines - infanrix penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis.

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

sanofi-aventis australia pty ltd - pertussis fimbriae 2 + 3; pertussis filamentous haemagglutinin; tetanus toxoid; diphtheria toxoid; pertactin; pertussis toxoid -

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

sanofi-aventis australia pty ltd - pertussis fimbriae 2 + 3; pertussis toxoid; pertactin; diphtheria toxoid; tetanus toxoid; poliovirus; pertussis filamentous haemagglutinin -

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (> or =); pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid 40 [iu] (> or =); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (as prp (target fill 10mcg + 2.5mcg overage)); diphtheria toxoid, adsorbed 30 [iu] (> or =); pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid 40 [iu] (> or =) - suspension for injection - active: diphtheria toxoid, adsorbed 30 [iu] (> or =) pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid 40 [iu] (> or =) excipient: aluminium hydroxide sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (as prp (target fill 10mcg + 2.5mcg overage)) excipient: lactose monohydrate sodium chloride water active: diphtheria toxoid, adsorbed 30 [iu] (> or =) pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid 40 [iu] (> or =) excipient: aluminium hydroxide phenoxyethanol sodium chloride water for injection - infanrixtm-hib is indicated for active immunisation against diphtheria, tetanus, pertussis (dtp) and haemophilus influenzae type b (hib) infection in all children from 15 months of age.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - tetanus toxoid; diphtheria toxoid; pertussis toxoid; filamentous haemagglutinin (fha); pertactin; polio virus type 1 inactivated; polio virus type 2 inactivated; polio virus type 3 inactivated; adsorbed aluminium phosphate; adsorbed fimbriae types 2 + 3 - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus

Israel - English - Ministry of Health

medici medical ltd, israel - diphtheria toxoid; filamentous haemagglutinin (fha); fimbrae tupes 2 + 3 (fim); pertactin; pertussis acellular; tetanus toxoid - suspension for injection - pertussis acellular 10 mcg / 0.5 ml; filamentous haemagglutinin (fha) 5 mcg / 0.5 ml; fimbrae tupes 2 + 3 (fim) 5 mcg / 0.5 ml; pertactin 3 mcg / 0.5 ml; diphtheria toxoid 30 iu / 0.5 ml; tetanus toxoid 40 iu / 0.5 ml - pertussis, purified antigen, combinations with toxoids - pertussis, purified antigen, combinations with toxoids - is indicated for the primary immunization of infants at or above the age of 2 months and as a booster in children up to their 6th birthday against diphtheria, tetanus and pertussis.

Israel - English - Ministry of Health

sanofi israel ltd - conjugated to tetanus protein; diphtheria toxoid; filamentous haemagglutinin (fha); haemophilus influenzae type b polysaccharide; pertussis toxoid (pt); polio type i (mohoney); polio type ii ( m.e.f.1); polio type iii (saukett); tetanus toxoid - powder and suspension for suspension for injection - polio type iii (saukett) 32 du / 0.5 ml; polio type ii ( m.e.f.1) 8 du / 0.5 ml; polio type i (mohoney) 40 du / 0.5 ml; filamentous haemagglutinin (fha) 25 mcg / 0.5 ml; pertussis toxoid (pt) 25 mcg / 0.5 ml; tetanus toxoid 40 iu / 0.5 ml; diphtheria toxoid 30 iu / 0.5 ml; haemophilus influenzae type b polysaccharide 10 mcg / 0.5 ml; conjugated to tetanus protein 18-30 mcg / 0.5 ml - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus - active immunisation against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by haemophilus influenzae type b (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, …)• for primary vaccination in infants.• for booster in children who have previously received a primary vaccination with this vaccine or a diphtheria-tetanus-whole-cell or acellular pertussis poliomyelitis vaccine, whether mixed or not with freeze-dried conjugate haemophilus influenzae type b vaccine.

European Union - English - EMA (European Medicines Agency)

mcm vaccine b.v. - 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 - vaccines - vaxelis (dtap-hb-ipv-hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib). the use of vaxelis should be in accordance with official recommendations.

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin; pertussis toxoid; diphtheria toxoid; tetanus toxoid; pertactin -

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

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