Irlanda - inglés - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - hepatitis a vaccine - solution for injection - 25iu/0.5 m units/ml - hepatitis vaccines

Singapur - inglés - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid; filamentous haemagglutinin; hepatitis b surface antigen (purified); hib purified capsular polysaccharide bound to tetanus toxoid; pertactin (69 kda omp); pertussis toxoid; poliovirus type 1 (inactivated); poliovirus type 2 (inactivated); poliovirus type 3 (inactivated) - injection - min 30 iu/0.5 ml - diphtheria toxoid min 30 iu/0.5 ml; filamentous haemagglutinin 25 mcg/0.5 ml; hepatitis b surface antigen (purified) 10 mcg/0.5 ml; hib purified capsular polysaccharide bound to tetanus toxoid 10 mcg/0.5 ml; pertactin (69 kda omp) 8 mcg/0.5 ml; pertussis toxoid 25 mcg/0.5 ml; poliovirus type 1 (inactivated) 40 du/0.5 ml; poliovirus type 2 (inactivated) 8 du/0.5 ml; poliovirus type 3 (inactivated) 32 du/0.5 ml

Irlanda - inglés - 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

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

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 400 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5 ml;  ; hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5ml - suspension for injection - 720 elisa u/0.5ml - active: hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5 ml   excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate polysorbate 20 potassium chloride sodium chloride active: hepatitis a vaccine 1440 eu/ml equivalent to 720 eu/0.5ml excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate phenoxyethanol polysorbate 20 potassium chloride sodium chloride - havrix is indicated for active immunisation against hav infection in subjects at risk of exposure to hav. havrix will not prevent hepatitis infection caused by other agents such as hepatitis b virus, hepatitis c virus, hepatitis e virus or other pathogens known to infect the liver. in areas of low and intermediate prevalence of hepatitis a, immunisation with havrix is particularly recommended in subjects who are, or will be, at increased risk of infection.

Malta - inglés - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, fimbriae types, and, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 3 µg pertussis toxoid 20 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu diphtheria toxoid filamentous haemagglutinin (fha) 20 µg fimbriae types 2 and 3 5 µg haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - hepatitis b virus surface antigen; hepatitis a virus inactivated - suspension for injection

Malta - inglés - Medicines Authority

mint health ltd 3/4, cantrija complex, triq it-targa, il-maghtab naxxar. nxr6613, malta - hepatitis a, virus, inactivated, elisa - suspension for injection in pre-filled syringe - hepatitis a virus (inactivated) 1440 elisa unit - vaccines

Malta - inglés - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - hepatitis a, virus, inactivated - suspension for injection - hepatitis a virus (inactivated) 720/0.5 u/ml - vaccines

Israel - inglés - Ministry of Health

glaxo smith kline (israel) ltd - purified hepatitis b antigen - suspension for injection - purified hepatitis b antigen 20 mcg / 1 ml - hepatitis b, purified antigen - hepatitis b, purified antigen - engerix b is indicated for active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes in non immune subjects .. the 20 µg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. the 10 µg dose vaccine in 0.5 ml suspension is intended for use in subjects up to and including 15 years of age, including neonates. the categories within the population to be immunised are determined on the basis of official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with engerix b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.