Lymphoseek
Withdrawn
This medicine's authorisation has been withdrawn
tilmanocept
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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The European Public Assessment Report (EPAR) for Lymphoseek is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IB/0023/G
10/06/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
News on Lymphoseek
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