Canada - English - Health Canada

aventis pasteur limited - poliomyelitis vaccine (inactivated); tetanus toxoid - liquid - 80unit; 5unit - poliomyelitis vaccine (inactivated) 80unit; tetanus toxoid 5unit - toxoids

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - polio virus type 1 300000 tcid50; polio virus type 2 100000 tcid50; polio virus type 3 300000 tcid50 - oral suspension - 0.5 ml - active: polio virus type 1 300000 tcid50 polio virus type 2 100000 tcid50 polio virus type 3 300000 tcid50 excipient: albumin magnesium chloride hexahydrate phenolsulfonphthalein

Malta - English - Medicines Authority

smithkline beecham limited - pertactin; pertussis filamentous haemagglutinin; pertussis toxoid; poliovirus (inactivated) type 1 (mahoney strain); poliovirus (inactivated) type 2 (mef-1 strain); poliovirus (inactivated) type 3 (saukett strain); diphtheria toxoid; haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate); tetanus toxoid - powder and suspension for suspension for injection - pertactin 8 µg; pertussis filamentous haemagglutinin 25 µg; pertussis toxoid 25 µg; poliovirus (inactivated) type 1 (mahoney strain) 40 dagu/0.5ml; poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu/0.5ml; poliovirus (inactivated) type 3 (saukett strain) 32 dagu/0.5ml; diphtheria toxoid; haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg; tetanus toxoid - vaccines

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - 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 - vaccines - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenzae type-b.

Bangladesh - English - DGDA (Directorate General of Drug Administration)

incepta pharmaceuticals ltd., vaccine division - poliomyelitis vacine, live (oral) - vaccine - .1 ml/.1 ml

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - (acellular pertussis) filamentous haemagglutinin adsorbed (fha); (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim); (acellular pertussis) pertactin adsorbed (prn); (acelullar pertussis) pertussis toxoid adsorbed (pt); diphtheria toxoid adsorbed; inactivated poliomyelitis vaccine (ipv) type 1 mahoney; inactivated poliomyelitis vaccine (ipv) type 2 (mef-1); inactivated poliomyelitis vaccine (ipv) type 3 (saukett); tetanus toxoid adsorbed - injection, suspension - (acellular pertussis) filamentous haemagglutinin adsorbed (fha) 5 µg/ 0.5 ml; (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim) 5 µg/0.5 ml; (acellular pertussis) pertactin adsorbed (prn) 3 µg/0.5 ml; (acelullar pertussis) pertussis toxoid adsorbed (pt) 2.5 µg/ 0.5 ml; diphtheria toxoid adsorbed 2lf; inactivated poliomyelitis vaccine (ipv) type 1 mahoney 40 d-antigen units; inactivated poliomyelitis vaccine (ipv) type 2 (mef-1) 8 d-antigen units; inactivated poliomyelitis vaccine (ipv) type 3 (saukett) 32 d-antigen units; tetanus toxoid adsorbed 5lf

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 2.5ug; polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)); polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)); polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)); tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 2.5ug polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)) polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)) polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)) tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) excipient: aluminium phosphate ethanol phenoxyethanol polysorbate 80 water for injection - adacel® polio is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation. children 4-6 years of age should have already received four doses of dtpa and ipv or opv. adacel® polio is not intended for primary immunisation. adacel® polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus. the use of adacel® polio should be determined on the basis of official recommendations.

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

sanofi-aventis australia pty ltd - tetanus toxoid, quantity: 40 iu; pertussis fimbriae 2 + 3, quantity: 5 microgram; diphtheria toxoid, quantity: 30 iu; poliovirus, quantity: 29 dagu; poliovirus, quantity: 26 dagu; poliovirus, quantity: 7 dagu; pertussis toxoid, quantity: 20 microgram; pertactin, quantity: 3 microgram; pertussis filamentous haemagglutinin, quantity: 20 microgram - injection, suspension - excipient ingredients: polymyxin b sulfate; bovine serum albumin; formaldehyde; phenoxyethanol; glutaral; neomycin; water for injections; polysorbate 80; aluminium phosphate - quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis, and poliomyelitis.,quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - diphtheria toxoid; tetanus toxoid; poliovirus, type 1; poliovirus, type 2; poliovirus, type 3 - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-poliomyelitis-tetanus

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - inactivated poliomyelitis virus,type 3; inactivated poliomyelitis virus,type 2; inactivated poliomyelitis virus,type 1 -