EMEA-001285-PIP01-12-M02

Key facts

Invented name
Unituxin
Active substance
Dinutuximab
Therapeutic area
Oncology
Decision number
P/0208/2013
PIP number
EMEA-001285-PIP01-12-M02
Pharmaceutical form(s)
Solution for infusion
Condition(s) / indication(s)
Treatment of neuroblastoma
Route(s) of administration
Intravenous use
Contact for public enquiries
United Therapeutics Europe Limited
United Kingdom
Tel. +44 (0)1932 573800
Fax +44 (0)1932 571110
E-mail: info1@unither.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001285-PIP01-12-M02
Compliance opinion date
16/12/2016
Compliance outcome
positive

Decision

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