New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - tuberculin purified protein derivative 27mg (freeze dried attentuated strain-mycobacterium bovis) - powder for injection - 27 mg - active: tuberculin purified protein derivative 27mg (freeze dried attentuated strain-mycobacterium bovis) excipient: monosodium glutamate dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride water for injection

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

aj vaccines a/s, denmark - mycobacterium bovis - danish strain 1331 - solution - 0.75 mg/ml

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

mycobacterium bovis (danish strain 1331) 2-8 10^6 cfu/ml -

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - bcg strain - powder for solution for instillation - bcg strain 200 - 800 miu - bcg vaccine - bcg vaccine - oncotice is used as a treatment of flat urothelial cell carcinoma in situ (cis) of the bladder and as an adjuvant therapy after transurethral resection (tur) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage ta (grade 2 or 3) or t1 (grade 1 2 or 3). oncotice is only recommended for stage ta grade 1 papillary tumors when there is judged to be a high risk of tumor recurrence.

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

merck sharp & dohme (australia) pty ltd - mycobacterium bovis (bacillus calmette and guerin (bcg) strain), quantity: 200000000 cfu - injection, powder for - excipient ingredients: citric acid monohydrate; ferric ammonium citrate; strong ammonia solution; purified water; asparagine; magnesium sulfate heptahydrate; zinc formate dihydrate; lactose monohydrate; dibasic potassium phosphate; glycerol - onco tice is used as a treatment of primary or recurrent carcinomain situ of the urinary bladder. onco tice is also used after transurethral resection for the prevention or recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (viz papillary carcinoma stage ta or t1 - grades 1, 2, or 3) indications as at 3 october 2001: oncotice is used as a treatment ofthe urinary bladder. oncotice is also used after transurethral resection for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carinoma of the urinary bladder (viz papillary carcinoma stage ta (grade 2 or 3) or t1 (grade 1, 2, or 3). oncotice is only recommended for stage ta grade 1 tumours, when there is judged to be a high risk of tumour recurrence is considered likely. inidications as at 24 april 2002: oncotice is used as a treatment of primary of recurrent carcinoma in situ (cid) of the urinary bladder. oncotice is also used after transurethral resection for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (viz papillary carcinoma stage ta (grade 2 or 3) or t1 (grade 1, 2, or 3). oncotice is only reccommended for stage ta grade 1 tumours, when there is judged to be a high risk of tumour recurrence.

Namibia - English - Namibia Medicines Regulatory Council

litha vaccines (pty) ltd - tb vaccine - injection - each 1ml solution contains mycobacterium bovis 0.75 mg (danish 1331)

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

radiantaire sdn bhd - bcg live -

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

radiantaire sdn bhd - bcg live -

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

novavive australasia pty ltd - mycobacterium cell wall fraction - unknown - mycobacterium cell wall fraction ungrouped active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - mycobacterium paratuberculosis - unknown - mycobacterium paratuberculosis vaccine active 0.0 - active constituent