Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Fintepla 2.2 mg/mL oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless, slightly viscous liquid, with a pH of 5. |
Each mL contains 2.2 mg of fenfluramine (as fenfluramine hydrochloride).
Excipient(s) with known effect:
Glucose (maize): 0.627 mg/mL
Sodium ethyl para-hydroxybenzoate (E215): 0.23 mg/mL
Sodium methyl para-hydroxybenzoate (E219): 2.3 mg/mL
Sulfur dioxide (E220): 0.000009 mg/mL
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fenfluramine |
Fenfluramine is a serotonin releasing agent, and thereby stimulates multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain, including the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sigma-1 receptor. The precise mode of action of fenfluramine in Dravet syndrome and Lennox-Gastaut syndrome is not known. |
| List of Excipients |
|---|
|
Sodium ethyl para-hydroxybenzoate (E215) Cherry flavouring powder: Acacia (E414) Potassium citrate (E332) |
Fintepla is presented in a white High Density Polyethylene (HDPE) bottle with a child-resistant, tamper-evident cap packaged in a carton, a Low Density Polyethylene (LDPE) press-in bottle adaptor, and Polypropylene (PP)/HDPE oral syringes. The oral syringe included in the pack should be used to administer the prescribed dose.
Presentations:
Bottle containing 60 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.
Bottle containing 120 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.
Bottle containing 250 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.
Bottle containing 360 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.
Not all pack sizes may be marketed.
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
EU/1/20/1491/001
EU/1/20/1491/002
EU/1/20/1491/003
EU/1/20/1491/004
Date of first authorisation: 18 December 2020
| Drug | Countries | |
|---|---|---|
| FINTEPLA | Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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