Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Immedica Pharma AB, SE-113 29, Stockholm, Sweden
RAVICTI 1.1 g/ml oral liquid.
| Pharmaceutical Form |
|---|
|
Oral liquid. Clear, colourless to pale yellow liquid. |
Each ml of liquid contains 1.1g of glycerol phenylbutyrate. This corresponds to a density of 1.1 g/ml.
The product contains no excipients.
| Active Ingredient | Description | |
|---|---|---|
| Glycerol phenylbutyrate |
Glycerol phenylbutyrate is a nitrogen-binding medicinal product. Urea cycle disorders (UCDs) are inherited deficiencies of enzymes or transporters necessary for the synthesis of urea from ammonia (NH3, NH4+). Absence of these enzymes or transporters results in the accumulation of toxic levels of ammonia in the blood and brain of affected patients. Glycerol phenylbutyrate is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs). |
| List of Excipients |
|---|
|
None. |
Clear, Type III glass, bottle with a high density polyethylene (HDPE) child-resistant closure.
Each bottle contains 25 ml of liquid.
Each bottle should be discarded after 14 days. Based on prescribed dosing volume, patients should be advised to obtain CE marked oral syringes with suitable size for the dosage and compatible with the reclosable bottle cap adapter from the pharmacy. Patients should be advised to have a sufficient quantity of syringes on hand.
Standard pack size: 1 bottle and 1 reclosable bottle cap adapter per carton.
Immedica Pharma AB, SE-113 29, Stockholm, Sweden
EU/1/15/1062/001
Date of first authorisation: 27 November 2015
| Drug | Countries | |
|---|---|---|
| RAVICTI | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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