RAVICTI Oral liquid Ref.[7687] Active ingredients: Glycerol phenylbutyrate

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Immedica Pharma AB, SE-113 29, Stockholm, Sweden

Product name and form

RAVICTI 1.1 g/ml oral liquid.

Pharmaceutical Form

Oral liquid.

Clear, colourless to pale yellow liquid.

Qualitative and quantitative composition

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.

Pack sizes and marketing

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.

Marketing authorization holder

Immedica Pharma AB, SE-113 29, Stockholm, Sweden

Marketing authorization dates and numbers

EU/1/15/1062/001

Date of first authorisation: 27 November 2015

Drugs

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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