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.

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

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)

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - recombinant cholera toxin b subunit 1mg; vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated); vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated); vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) - oral suspension - active: recombinant cholera toxin b subunit 1mg vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated) vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated) vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate dihydrate citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate - active immunisation of adults and children from two years of age, who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. the vaccine should be considered for foreign aid workers and others intending to visit or spend an extended period of time in areas endemic or epidemic for cholera.

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.

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

valneva uk ltd - vibrio cholerae - oral suspension

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

csl limited - vibrio cholerae -

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

aj biologics sdn. bhd. - v.cholerae ogawa 50 classical biotype,; v.cholerae ogawa 50 classical biotype,; recombinant cholera toxin b subunit (rctb-213); v.cholerae inaba 48 classical biotype,; v.cholerae inaba 6973 el tor biotype, -

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

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.