SomaKit TOC (edotreotide)
- Region
- 🇪🇺 EU
- Active substance
- edotreotide
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Neuroendocrine Tumors; Radionuclide Imaging
- CHMP opinion
- Thu 15 Sep 2016
- EU approval
- Thu 08 Dec 2016
- Designations
- Orphan
- Application
- EMEA/H/C/004140
- ATC
- V09IX
- Official record
- www.ema.europa.eu
Indication
This medicinal product is for diagnostic use only. After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.