New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - haemophilus influenzae type b prp 5ug (conjugated with 12.5 mcg tetanus toxoid);  ; neisseria meningitidis group c polysaccharide 5ug (5 mcg men c polysaccharide conjugated to 5 mcg tetanus toxoid) - injection with diluent - 0.5 ml - active: haemophilus influenzae type b prp 5ug (conjugated with 12.5 mcg tetanus toxoid)   neisseria meningitidis group c polysaccharide 5ug (5 mcg men c polysaccharide conjugated to 5 mcg tetanus toxoid) excipient: sodium chloride sucrose tetanus toxoid trometamol hydrochloride sodium chloride water for injection - menitorix is indicated for the prevention of invasive diseases caused by haemophilus influenzae type b (hib) and neisseria meningitidis serogroup c (menc).

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - diphtheria toxoid tetanus toxoid pertussis toxoid filamentous haemagglutinin (fha) pertactin polio virus type 1 inactivated polio virus type 2 inactivated polio virus type 3 inactivated haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid tetanus vaccine adsorbed - %v/v

Malta - Ingliż - 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

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-a and hepatitis-b infection.protection against hepatitis-b infections may not be obtained until after the second dose.therefore:ambirix should be used only when there is a relatively low risk of hepatitis-b infection during the vaccination course;it is recommended that ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

Unjoni Ewropea - Ingliż - 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).

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - diphtheria toxoid; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; human poliovirus type 3 inactivated; haemophilus influenzae type b polysaccharide protein conjugate - powder and suspension for suspension for injection

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified tetanus toxoid; purified diphtheria toxoid ph. eur.; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - diphtheria toxoid; tetanus toxoid; pertussis toxoid; filamentous haemagglutinin (fha); pertactin; type 1 (mahoney); type 2 (mef-1); type 3 (saukett) - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - diphtheria-pertussis-poliomyelitis-tetanus

Kanada - Ingliż - 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

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pneumococcal purified capsular polysaccharides, quantity: 2.2 microgram; pneumococcal purified capsular polysaccharides, quantity: 4.4 microgram - injection, suspension - excipient ingredients: aluminium phosphate; water for injections; polysorbate 80; diphtheria crm197 protein; succinic acid; sodium chloride - 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.