Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: SomaKit TOC   
Auth. number : EU/1/16/1141
Active substance : edotreotide
Orphan market exclusivity for "Diagnosis of gastro-entero-pancreatic neuroendocrine tumours" (based on designation EU/3/15/1450) started on 12/12/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 12/12/2026
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09I - Tumour detection
Chemical subgroup: V09IX - Other diagnostic radiopharmaceuticals for tumour detection
Chemical substance: V09IX09 - gallium (68Ga) edotreotide
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Advanced Accelerator Applications
20 rue Diesel, 01630 Saint-Genis-Pouilly, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
12/12/2016 Centralised - Authorisation EMEA/H/C/4140 (2016)8515 of 8/12/2016
5/04/2017 Centralised - Notification EMEA/H/C/4140/N/1
Updated with Decision(2018)3762 of 07/06/2018
8/05/2017 Centralised - Notification EMEA/H/C/4140/N/2
Updated with Decision(2018)3762 of 07/06/2018
12/06/2017 Centralised - Variation EMEA/H/C/4140/IB/3
Updated with Decision(2018)3762 of 07/06/2018
8/03/2018 Corrigendum (2016)8515 of 8/12/2016
11/06/2018 Centralised - Yearly update (2018)3762 of 7/06/2018
1/10/2018 Centralised - Variation EMEA/H/C/4140/IB/6
17/12/2018 Centralised - Notification EMEA/H/C/4140/N/09