EMEA-002503-PIP01-18
Key facts
| Invented name |
HBED Trasis
|
| Active substance |
Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic acid (PSMA11-HBED-CC) (HBED Trasis)
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0208/2019
|
| PIP number |
EMEA-002503-PIP01-18
|
| Pharmaceutical form(s) |
Kit for radiopharmaceutical preparation
|
| Condition(s) / indication(s) |
Visualisation of prostate specific membrane antigen in prostate cancer
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Trasis S.A.
Tel.: +32 4988780 |
| Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|