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.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur msd, snc - purified diphtheria toxoid, purified tetanus toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis b surface antigen, inactivated type 1 poliovirus (mahoney), inactivated type 2 poliovirus (mef 1), inactivated type 3 poliovirus (saukett), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - this combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis b caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by haemophilus influenzae type b.

Canada - English - Health Canada

sanofi pasteur limited - inactivated poliomyelitis vaccine (d.c.o.) type 2 mef1; inactivated poliomyelitis vaccine (d.c.o.) type 3 saukett; inactivated poliomyelitis vaccine (d.c.o.) type 1 mahoney - solution - 8unit; 32unit; 40unit - inactivated poliomyelitis vaccine (d.c.o.) type 2 mef1 8unit; inactivated poliomyelitis vaccine (d.c.o.) type 3 saukett 32unit; inactivated poliomyelitis vaccine (d.c.o.) type 1 mahoney 40unit - vaccines

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

live attenuated poliovirus type 1 sabin strain stabilized with mg c12 1m

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - rotavirus serotype g1, serotype g2, serotype g3, serotype g4, serotype p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection.rotateq is to be used on the basis of official recommendations.

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

merck sharp & dohme (malaysia) sdn bhd - live attenuated measles virus; live attenuated rubella virus; live attenuated mumps virus -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

serum institute of india pvt. ltd. (siipl), india - live attenuated rotavirus vaccine - lyophilized powder for reconstitution - 10^5.6 ffu/serotype

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

serum institute of india pvt. ltd. (siipl), india - live attenuated rotavirus vaccine - lyophilisade for the preparation of injection suspension with diluent - 10^5.6 ffu/serotype

Malta - English - Medicines Authority

bilthoven biologicals b.v. antonie van leeuwenhoeklaan 9 3721 ma, bilthoven, netherlands - suspension for injection - poliovirus (inactivated) type 3 (saukett strain) 7.5 dagu diphtheria toxoid >5 iu tetanus toxoid >20 iu poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 4 dagu - vaccines

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

glaxosmithkline australia pty ltd - tetanus toxoid, quantity: 20 lfu/ml; poliovirus, quantity: 80 agu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; poliovirus, quantity: 16 agu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 64 agu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, solution - excipient ingredients: aluminium hydroxide hydrate; water for injections; neomycin sulfate; polymyxin b sulfate; sodium chloride; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - 1. infanrix-ipv is indicated for use in a three dose primary schedule for immunisation of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis and poliomyelitis. infanrix-ipv is also indicated as a single booster dose for children, up to and including 6 years of age, who have previously been immunised against diphthereia, tetanus, pertussis and polio.