Key facts

Active Substance
half-life extended bispecific T-cell engager (BiTE) antibody construct that binds to prostate-specific membrane antigen and cluster of differentiation 3, with a single chain fragment crystallizable moiety
Therapeutic area
Oncology
Decision number
P/0303/2020
PIP number
EMEA-002655-PIP02-20
Pharmaceutical form(s)
Powder for solution for infusion
Condition(s) / indication(s)
Treatment of prostate cancer
Route(s) of administration
Intravenous use
Contact for public enquiries

Amgen Europe BV

E-mail: medinfointernational@amgen.com
Tel. +44 (0)1223 420305

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

Decision

P/0303/2020 : EMA decision of 12 August 2020 on the granting of a product specific waiver for half-life extended bispecific T-cell engager (BiTE) antibody construct.......(EMEA-002655-PIP02-20)

AdoptedReference Number: EMA/414860/2020

English (EN) (142.62 KB - PDF)

First published:
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