Irlande - anglais - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - feiba - pdr+solv for soln for inf - 500

Irlande - anglais - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - feiba - pdr+solv for soln for inf - 1000

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 1000 u;  ;   - powder for injection with diluent - 1000 u - active: factor viii inhibitor bypassing fraction 1000 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 2500 u;  ;   - powder for injection with diluent - 2500 u - active: factor viii inhibitor bypassing fraction 2500 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

takeda new zealand limited - factor viii inhibitor bypassing fraction 500 u;  ;   - powder for injection with diluent - 500 u - active: factor viii inhibitor bypassing fraction 500 u     excipient: sodium chloride sodium citrate dihydrate water for injection - feiba nf is indicated for treatment of haemorrhage and to cover surgical interventions in: · haemophilia a patients with factor viii inhibitors · haemophilia b patients with factor ix inhibitors. feiba nf is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia a subjects with inhibitors experiencing >/= 12 bleeding episodes per year. prophylaxis with feiba nf is recommended for patients with high titer (>5bu) inhibitor or low titer (<5 bu) inhibitor, refractory to increased dosing with fviii or fix.

Irlande - anglais - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - feiba - pdr+solv for soln for inf - 50 units/ml

Irlande - anglais - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - feiba - pdr+solv for soln for inf - 25 units/ml

Malaisie - anglais - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - factor viii bypassing fraction -

Malaisie - anglais - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - factor viii bypassing fraction -