Lymphoseek

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tilmanocept

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Lymphoseek. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lymphoseek.

For practical information about using Lymphoseek, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 10/01/2018

Authorisation details

Product details
Name
Lymphoseek
Agency product number
EMEA/H/C/002085
Active substance
tilmanocept
International non-proprietary name (INN) or common name
tilmanocept
Therapeutic area (MeSH)
Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
V09IA09
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Norgine BV
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
19/11/2014
Contact address
Hogehilweg 7
1101 CAAmsterdam Zuidoost
Netherlands

Product information

16/11/2017 Lymphoseek - EMEA/H/C/002085 - IAIN/0011/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • diagnostic radiopharmaceutical
  • TUMOUR DETECTION

Therapeutic 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.

Assessment history

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