Lymphoseek

Withdrawn

This medicine's authorisation has been withdrawn

tilmanocept

Overview

The marketing authorisation for Lymphoseek (SRD) has been withdrawn at the request of the marketing-authorisation holder.

Lymphoseek : EPAR - Summary for the public

Reference Number: EMA/601221/2014

Lymphoseek : EPAR - Risk-management-plan summary

Product information

Lymphoseek : EPAR - Product Information

Lymphoseek : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Lymphoseek
• Active substance:
  tilmanocept
• International non-proprietary name (INN) or common name:
  tilmanocept
• Therapeutic area (MeSH):
  Radionuclide Imaging
• Anatomical therapeutic chemical (ATC) code:
  V09IA09

Pharmacotherapeutic group

• Tumour detection
• Diagnostic radiopharmaceuticals

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002085
• Marketing authorisation holder:
  Navidea Biopharmaceuticals Europe Ltd.

  Kilminion South; Ballinroad; Dungarvan; Co. Waterford, X35 WP70; Ireland

• Opinion adopted:
  25/09/2014
• Marketing authorisation issued:
  19/11/2014
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Lymphoseek : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Lymphoseek : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/264502/2014

CHMP summary of positive opinion for Lymphoseek

AdoptedReference Number: EMA/CHMP/525445/2014