EMEA-002101-PIP02-18

Key facts

Active substance
iodine (131-I) murine IgG1 monoclonal antibody against B7-H3 (131I-omburtamab)
Therapeutic area
Oncology
Decision number
P/0405/2019
PIP number
EMEA-002101-PIP02-18
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
Treatment of neuroblastoma
Route(s) of administration
Intracerebral use
Contact for public enquiries
Y-mAbs Therapeutics A/S

E-mail: jow@ymabs.com
Tel. +45 70261414

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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