Philippines - English - FDA (Food And Drug Administration)

ulivaccines, inc.; distributor: gb distributors inc. - cholera vaccine (inactivated, oral) - enteric-coated capsule - formulation each capsule contains: inactivated whole cell (wc)-5.0 x 10^10 of vibrio cholerae 01 inaba, classical biotype (heat inactivated) recombinant cholera toxin b subunit (ictb)--1 mg (produced in v. cholerae 01 inaba, classical biotype or el tor biotype)

Canada - English - Health Canada

aventis pasteur limited - cholera vaccine - suspension - 8000m - cholera vaccine 8000m - vaccines

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

averroes pharmaceuticals sdn. bhd. - v.cholerae inaba 48 classical biotype,; v.cholerae inaba 6973 el tor biotype,; v.cholerae ogawa 50 classical biotype,; v.cholerae ogawa 50 classical biotype,; vibrio cholerae 0139, strain 4260 b, inactivated -

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

seqirus pty ltd - vibrio cholerae, quantity: 31.25 billion organisms; vibrio cholerae, quantity: 1 mg - oral liquid, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate dihydrate; water for injections; monobasic sodium phosphate dihydrate - cholera caused by serogroup 01 vibrio cholerae: active immunisation of adults and children from two years of age, who will be visiting areas epidemic or endemic for cholera and who are at high risk of infection.

European Union - English - EMA (European Medicines Agency)

valneva sweden ab - recombinant cholera toxin b subunit, vibrio cholerae 01 - cholera; immunization - vaccines - dukoral is indicated for active immunisation against disease caused by vibrio cholerae serogroup o1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.the use of dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.dukoral should not replace standard protective measures. in the event of diarrhoea measures of rehydration should be instituted.

Canada - English - Health Canada

valneva sweden ab - vibrio cholerae ogawa 50 classical biotype, formalin inactivated; recombinant cholera toxin b subunit; vibrio cholerae inaba 6973 el tor biotype, formalin inactivated; vibrio cholerae inaba 48 classical biotype, heat inactivated; vibrio cholerae ogawa 50 classical biotype, heat inactivated - suspension - 31250000000cells; 1mg; 31250000000cells; 31250000000cells; 31250000000cells - vibrio cholerae ogawa 50 classical biotype, formalin inactivated 31250000000cells; recombinant cholera toxin b subunit 1mg; vibrio cholerae inaba 6973 el tor biotype, formalin inactivated 31250000000cells; vibrio cholerae inaba 48 classical biotype, heat inactivated 31250000000cells; vibrio cholerae ogawa 50 classical biotype, heat inactivated 31250000000cells - vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - cholera vaccine 8000 million organisms/ml (equal parts of inaba and ogawa types) - solution for injection - 8000 million organisms/ml - active: cholera vaccine 8000 million organisms/ml (equal parts of inaba and ogawa types) excipient: dibasic sodium phosphate dodecahydrate monobasic sodium phosphate dihydrate phenol sodium chloride water for injection

Singapore - English - HSA (Health Sciences Authority)

aenon pharmaceuticals sea pte. ltd. - recombinant cholera toxin b subunit (rctb); vibrio cholerae o1 inaba classic strain (heat inactivated); vibrio cholerae o1 inaba el tor strain (formalin inactivated); vibrio cholerae o1 ogawa classic strain (formalin inactivated); vibrio cholerae o1 ogawa classic strain (heat inactivated) - suspension - 1 mg/dose - recombinant cholera toxin b subunit (rctb) 1 mg/dose; vibrio cholerae o1 inaba classic strain (heat inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 inaba el tor strain (formalin inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 ogawa classic strain (formalin inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 ogawa classic strain (heat inactivated) 31.25 x 10^9 bacteria

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

valneva uk ltd - vibrio cholerae - oral suspension

European Union - English - EMA (European Medicines Agency)

bavarian nordic a/s - vibrio cholerae, strain cvd 103-hgr, live - cholera - vaccines - vaxchora is indicated for active immunisation against disease caused by vibrio cholerae serogroup o1 in adults and children aged 2 years and older.this vaccine should be used in accordance with official recommendations.