EMEA-000297-PIP02-12-M02

Key facts

Invented name
Ravicti
Active substance
Glycerol phenylbutyrate
Therapeutic area
Endocrinology, -gynacology-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
  • Oral use
  • Gastroenteral use
Contact for public enquiries
Horizon Pharma Ireland Limited

E-mail: regulatory-eu@horizonpharma.com
Tel.  +353 1772 2100

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

Decision

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