Lymphoseek (tilmanocept)
- Region
- 🇪🇺 EU
- Active substance
- tilmanocept
- Company
- Navidea Biopharmaceuticals Europe Ltd.
- Status
- Withdrawn
- Therapeutic area
- Radionuclide Imaging
- CHMP opinion
- Thu 25 Sep 2014
- EU approval
- Wed 19 Nov 2014
- Application
- EMEA/H/C/002085
- ATC
- V09IA09
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.