EMEA-000297-PIP02-12-M02
Key facts
| Invented name |
Ravicti
|
| Active substance |
Glycerol phenylbutyrate
|
| Therapeutic area |
Endocrinology-Gynaecology-Fertility-Metabolism
|
| Decision number |
P/0191/2018
|
| PIP number |
EMEA-000297-PIP02-12-M02
|
| Pharmaceutical form(s) |
Oral liquid
|
| Condition(s) / indication(s) |
Treatment of urea cycle disorders
|
| Route(s) of administration |
|
| Contact for public enquiries |
Horizon Pharma Ireland Limited
E-mail: regulatory-eu@horizonpharma.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000297-PIP02-12-M02
|
| Compliance opinion date |
21/09/2018
|
| Compliance outcome |
positive
|