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
|