FINTEPLA Oral solution Ref.[27912] Active ingredients:

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Product name and form

Fintepla 2.2 mg/mL oral solution.

Pharmaceutical Form

Oral solution.

Clear, colourless, slightly viscous liquid, with a pH of 5.

Qualitative and quantitative composition

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.

List of Excipients

Sodium ethyl para-hydroxybenzoate (E215)
Sodium methyl para-hydroxybenzoate (E219)
Sucralose (E955)
Hydroxyethylcellulose (E1525)
Monosodium phosphate (E339)
Disodium phosphate (E339)

Cherry flavouring powder:

Acacia (E414)
Glucose (maize)
Ethyl benzoate
Natural flavouring preparations
Natural flavouring substances
Flavouring substances
Maltodextrin (maize)
Sulfur dioxide (E220)

Potassium citrate (E332)
Citric acid monohydrate (E330)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Marketing authorization dates and numbers

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

Drugs

Drug Countries
FINTEPLA Estonia, France, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom, United States

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