EMEA-003058-PIP01-21

Table of contents

Key facts

Active substance
Humanised KLB/FGFR1c monoclonal antibody (MK-3655)
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0186/2022
PIP number
EMEA-003058-PIP01-21
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of non-alcoholic steatohepatitis (NASH)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Merck Sharp & Dohme (Europe), Inc.

Email: pip.information@merck.com
Tel. +31 412663179

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

Decision

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