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)
|