On 10 June 2024, the European Commission withdrew the marketing authorisation for Lymphoseek (tilmanocept) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Navidea Biopharmaceuticals Europe Ltd., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Lymphoseek was granted marketing authorisation in the EU on 19 November 2014 for use in the delineation and localisation of lymph nodes. The marketing authorisation was initially valid for a 5-year period. It was granted unlimited validity in 2019. The European Public Assessment Report (EPAR) for Lymphoseek is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
V09IA09
ATC Item
technetium (99mTc) tilmanocept
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| tilmanocept | N/A | Tilmanocept |
EMA Name
Lymphoseek
Medicine Name
Lymphoseek
Aliases
N/ANo risk management plan link.
