EMEA-001732-PIP02-15

Key facts

Active substance
Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414)
Decision number
P/0298/2016
PIP number
EMEA-001732-PIP02-15
Pharmaceutical form(s)
Powder for solution for injection or infusion
Condition(s) / indication(s)
Treatment of high-grade glioma
Route(s) of administration
Intravenous use
Contact for public enquiries
AbbVie Ltd
United Kingdom
Tel. +44 (0)1628 408248
Fax +44 (0)1628 672566
E-mail: paediatricteam@abbvie.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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