CHMP anser derfor ikke den foreslåede brede indikation “ blærecancer ” for at være berettiget, da de fremlagte data ikke er tilstrækkelige til at understøtte indikationen for overfladisk blærecancer.
Therefore the CHMP considers that the proposed broad indication “bladder cancer” is not justified, as the data provided was not sufficient to support the indication in superficial bladder cancer.