FLUDROCORTISONE MEDICIANZ, FLUDROCORTISONE MEDSURGE (Medicianz Healthcare Pty Ltd)
Product name
FLUDROCORTISONE MEDICIANZ, FLUDROCORTISONE MEDSURGE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 (255 working days)
Active ingredients
fludrocortisone acetate
Registration type
New generic medicine
Indication
FLUDROCORTISONE MEDICIANZ, FLUDROCORTISONE MEDSURGE is indicated for partial replacement therapy for primary adrenocortical insufficiency in Addison's disease and for the treatment of salt losing adrenogenital syndrome.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine