New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - bacillus calmette-guerin 0.75 mg/ml (when reconstituted with diluted sauton ajv (danish strain 1331) (vaccine)) - suspension for injection - 0.75 mg/ml - active: bacillus calmette-guerin 0.75 mg/ml (when reconstituted with diluted sauton ajv (danish strain 1331) (vaccine)) excipient: monosodium glutamate asparagine citric acid monohydrate dibasic potassium phosphate ferric ammonium citrate glycerol magnesium sulfate water for injection - active immunisation against tuberculosis

Singapore - English - HSA (Health Sciences Authority)

dksh singapore pte. ltd. - live attenuated mycobacterium bovis (bcg) danish 1331 - injection, powder, for solution - 0.75 mg/ml - live attenuated mycobacterium bovis (bcg) danish 1331 0.75 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

statens serum institute - mycobacterium bovis (bcg) stam 1331 - pdr+solv for susp for inj - %v/v - tuberculosis vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

aj vaccines a/s - mycobacterium bovis (bcg) stam 1331 - powder and solvent for suspension for injection - 0 colony forming unit(s)/millilitre - tuberculosis vaccines; tuberculosis, live attenuated

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

aj vaccines - mycobacterium bovis bcg danish strain 1331 - powder for injection

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

kahma biotech (pty) ltd - suspension - see ingredients - each vial contains mycobacterium bovis 30,0 mg

United Kingdom - English - VMD (Veterinary Medicines Directorate)

animal and plant health agency - mycobacterium bovis subsp. bovis - lyophilisate and solvent for suspension for injection - live bacterial vaccine - badger

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

the biovac institute - injection - see ingredients - each 1 ml solution contains mycobacterium bovis 0,75 mg (danish 1331)

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

serum institute of india pvt. ltd. - bcg vaccine(bacillus calmette guerin strain) - powder lyophilized for solution for injection - between 2x10^5 and 8x10^5 cfu/0,1ml

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

sanofi-aventis australia pty ltd - mycobacterium bovis (bacillus calmette and guerin (bcg) strain), quantity: 1.5 mg - injection, powder for - excipient ingredients: monosodium glutamate monohydrate - bcg vaccine is recommended for active immunisation in high risk groups. the nhmrc recommendation for bcg vaccination are: bcg is recommended for use in 3 groups of infants: . aboriginal and torres strait islander neonates in regions of high incidence; . neonates born to patients with leprosy; . children under the age of 5 years who will be travelling to live in countries of high tuberculosis prevalence for long periods. bcg vaccination should be considered for the following children and adolescents: .neonates who will be living in a household which includes immigrants or visitors recently arrived from countries of high prevalence (this also applies to neonates in families who have returned to visit the homes of relatives in countries of high prevalence); . children and adolescents aged less than 16 years who continue to be exposed to a patient with active tuberculosis, and where the child or adolescent cannot be placed on isoniazid therapy or the active case has organisms resistant to both isoniazid and rifam