Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lutathera   
Auth. number : EU/1/17/1226
Active substance : lutetium (177Lu) oxodotreotide
Orphan market exclusivity for "Treatment of gastro-entero-pancreatic neuroendocrine tumours" (based on designation EU/3/07/523) started on 28/09/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 28/09/2027
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V10 - Therapeutic radiopharmaceuticals
Pharmacological subgroup: V10X - Other therapeutic radiopharmaceuticals
Chemical subgroup: V10XX - Various therapeutic radiopharmaceuticals
Chemical substance: V10XX04 - lutetium (177Lu) oxodotreotide
(See WHO ATC Index)
Indication: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults.
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
28/09/2017 Centralised - Authorisation EMEA/H/C/4123 (2017)6642 of 26/09/2017
13/12/2017 Corrigendum (2017)6642 of 26/09/2017
15/01/2018 Corrigendum (2017)6642 of 26/09/2017
21/03/2018 Centralised - Variation EMEA/H/C/4123/IA/3
Updated with Decision(2019)2376 of 25/03/2019
22/08/2018 Corrigendum
17/12/2018 Centralised - Notification EMEA/H/C/004123/N/0008
Updated with Decision(2019)2376 of 25/03/2019
31/01/2019 Centralised - Variation EMEA/H/C/004123/II/0005
Updated with Decision(2019)2376 of 25/03/2019
27/03/2019 Centralised - Yearly update (2019)2376 of 25/03/2019