Monograph

The Ministry of Health’s Drug Advisory Committee has recommended:

• Agalsidase alfa 3.5 mg/3.5 mL concentrate for solution for infusion as an enzyme replacement therapy in patients with Fabry disease. The treatment may be initiated only in:
  a) Male patients with classical Fabry disease; or
  b) Male patients with non-classical Fabry disease, or female patients with classical or non-classical Fabry disease, who have signs/symptoms of organ involvement (e.g. kidney, heart or nervous system) consistent with Fabry disease and which are not fully explained by other pathology.

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