EMEA-001441-PIP05-20

Table of contents

Key facts

Invented name
Ozempic
Active substance
semaglutide
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0464/2021
PIP number
EMEA-001441-PIP05-20
Pharmaceutical form(s)
Solution for injection in pre-filled pen
Condition(s) / indication(s)
Treatment of non-alcoholic steatohepatitis (NASH)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Novo Nordisk A/S

Email: paediatrics@novonordisk.com
Tel: +45 44444848
 

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

Decision

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