Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Navidea Biopharmaceuticals Europe Ltd., Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland
Lymphoseek 50 micrograms kit for radiopharmaceutical preparation.
| Pharmaceutical Form |
|---|
|
Kit for radiopharmaceutical preparation. The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder. |
Each vial contains 50 micrograms of tilmanocept.
The radionuclide is not part of the kit.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Technetium ⁹⁹ᵐTc tilmanocept |
Technetium ⁹⁹ᵐTc tilmanocept is a receptor-targeted radiopharmaceutical that is designed to rapidly transit lymphatic vessels; it biotargets, accumulates, and is retained in primary, key predictive, draining lymph nodes (sentinel lymph nodes). |
| List of Excipients |
|---|
|
Trehalose dihydrate |
8 mL type I glass vial with a butyl rubber stopper sealed with a flip-off seal. Each vial contains 50 micrograms tilmanocept.
Pack-size of 1 and 5 vials.
Navidea Biopharmaceuticals Europe Ltd., Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland
EU/1/14/955/002
EU/1/14/955/001
Date of first authorisation: 19 November 2014
Date of latest renewal: 16 September 2019
| Drug | Countries | |
|---|---|---|
| LYMPHOSEEK | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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