P/8/2010

Key facts

Active substance
Teplizumab
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/8/2010
PIP number
P/8/2010
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of type I diabetes mellitus
Route(s) of administration
Intravenous use
Contact for public enquiries
MacroGenics, Inc.
E-mail: srowland@proventionbio.com
Tel. +1 4439 870797
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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