Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lymphoseek   
Auth. number : EU/1/14/955
Active substance : tilmanocept
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09I - Tumour detection
Chemical subgroup: V09IA - Technetium (99mTc) compounds
Chemical substance: V09IA09 - Technetium (99mTc) tilmanocept
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.
External imaging and intraoperative evaluation may be performed using a gamma detection device.
Marketing Authorisation Holder: Norgine B.V.
Hogehilweg 7, 1101CA Amsterdam, Nederland
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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/11/2014 Centralised - Authorisation EMEA/H/C/2085 (2014)8901 of 19/11/2014
15/09/2016 Centralised - Variation EMEA/H/C/2085/II/04
Updated with Decision(2017)437 of 23/01/2017
25/01/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2085/T/07 (2017)437 of 23/01/2017
16/09/2017 Centralised - Variation EMEA/H/C/2085/IB/10