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MYTOLAC (Amdipharm Mercury Australia Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
153 (255 working days)
Active ingredients
Lanreotide acetate
Registration type
New generic medicine

MYTOLAC is indicated for:

    the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory
  • the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours
  • the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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