EMEA-000482-PIP01-08-M06
Key facts
| Invented name |
Revestive
|
| Active substance |
teduglutide
|
| Therapeutic area |
Gastroentology-Hepatology
|
| Decision number |
P/0479/2020
|
| PIP number |
EMEA-000482-PIP01-08-M06
|
| Pharmaceutical form(s) |
Powder and solvent for solution for injection
|
| Condition(s) / indication(s) |
Treatment of short bowel syndrome
|
| Route(s) of administration |
Subcutaneous use
|
| Contact for public enquiries |
Takeda Pharmaceuticals International AG Ireland Branch
E-mail: medinfoemea@takeda.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000482-PIP01-08-M06
|
| Compliance opinion date |
26/03/2021
|
| Compliance outcome |
positive
|