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OCTREOTIDE DEPOT (Teva Pharma Australia Pty Ltd)
Product name
OCTREOTIDE DEPOT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
122 working days (175)
Active ingredients
octreotide
Registration type
New generic medicine
Indication
OCTREOTIDE DEPOT (solution for injection ) is indicated:
Acromegaly
For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment but who are adequately controlled on s.c. treatment with octreotide. Octreotide Depot is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.
Gastro-entero-pancreatic tumours
For the relief of symptoms associated with the following functional tumours of the gastro-enteropancreatic endocrine system:
- Carcinoid tumours with features of the carcinoid syndrome
- Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately controlled on subcutaneous treatment with octreotide
Octreotide Depot is not curative in these patient.
Advanced Neuroendocrine Tumours of the Midgut
Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.