EMEA-001441-PIP05-20
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 |
Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|