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), (EMEA-002503-PIP01-18)
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
E-mail: philippart@trasis.com

Decision type
W: decision granting a waiver in all age groups for all conditions/indications

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