EMEA-000245-PIP01-08-M06
Key facts
| Invented name |
Amitiza
|
| Active substance |
Lubiprostone
|
| Therapeutic area |
Gastroentology-Hepatology
|
| Decision number |
P/0363/2019
|
| PIP number |
EMEA-000245-PIP01-08-M06
|
| Pharmaceutical form(s) |
Capsule, soft
|
| Condition(s) / indication(s) |
Treatment of constipation
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Sucampo AG
E-mail: medinfo@mnk.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000245-PIP01-08-M06
|
| Compliance opinion date |
28/02/2020
|
| Compliance outcome |
positive
|