🇪🇺 Ga-68-DOTATOC in European Union

EMA authorised Ga-68-DOTATOC on 8 December 2016

Marketing authorisation

EMA — authorised 8 December 2016

  • Application: EMEA/H/C/004140
  • Marketing authorisation holder: Advanced Accelerator Applications
  • Local brand name: SomaKit TOC
  • 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.
  • Pathway: orphan
  • Status: approved

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Ga-68-DOTATOC in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Ga-68-DOTATOC approved in European Union?

Yes. EMA authorised it on 8 December 2016.

Who is the marketing authorisation holder for Ga-68-DOTATOC in European Union?

Advanced Accelerator Applications holds the EU marketing authorisation.