FINTEPLA sol 2.2 mg/ml buvable fl 360 ml

7680693710023 CH-69371 N03AX26 01.07.1.
FINTEPLA sol 2.2 mg/ml buvable fl 360 ml
FINTEPLA sol 2.2 mg/ml buvable fl 360 ml
FINTEPLA sol 2.2 mg/ml buvable fl 360 ml
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Details

GTIN
7680693710023
Pharmacode
-
Product number
6937101
CPT
-
Packaging group
360 ml
Unit
Flasche(n)
Composition
fenfluraminum 2.2 mg ut fenfluramini hydrochloridum, E 219 2.3 mg, E 215 0.23 mg, sucralosum, hydroxyethylcellulosum cum natrii dihydrogenophosphas et dinatrii phosphas, kalii citras, acidum citricum monohydricum, aromatica cerise cum glucosum, ethylis benzoas, maltodextrinum et E 220, aqua ad iniectabile ad solutionem pro 1 ml corresp. natrium 0.33 mg.

Articles (1)

Fintepla 2.2 mg/ml, solution buvable
Lösung
360 ml
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
09/07/2026
Professional SmPC
Français
09/07/2026
Professional SmPC
Italien
09/07/2026
Patient information leaflet
Allemand
11/04/2026
Patient information leaflet
Français
11/04/2026
Patient information leaflet
Italien
11/04/2026

Detailed composition

Substance Quantity Type Category
fenfluraminum
2.2 MG Substance Wirkstoff (Principe actif)
fenfluramini hydrochloridum
- Substance WIZUS
E 219
2.3 MG Substance HBESI
E 215
0.23 MG Substance HBESI
sucralosum
- Substance HNIDK
hydroxyethylcellulosum
- Substance HNIDK
natrii dihydrogenophosphas
- Substance HNIDK
dinatrii phosphas
- Substance HNIDK
kalii citras
- Substance HNIDK
acidum citricum monohydricum
- Substance HNIDK
aromatica
- Substance AROMA
glucosum
- Substance HBESI
ethylis benzoas
- Substance HBESI
maltodextrinum
- Substance HNIDK
E 220
- Substance HBESI
aqua ad iniectabile
- Substance HNIDK
natrium
0.33 MG Substance HBESI

Authorization holder

UCB-Pharma SA

1630 Bulle

Authorization information

Swissmedic authorization number
69371
Drug name
Fintepla, solution buvable
Galenic form
LSOR
ATC Code
N03AX26
Authorization status
Z
Dispensation category
A
First authorization
13/02/2025
Authorization expiration date
12/02/2030
IT number
01.07.1.
Domain
Human medicine
Field of application
Zusatztherapie bei Krampfanfällen in Zusammenhang mit dem Dravet-Syndrom (DS) oder dem Lennox-Gastaut-Syndrom (LGS), bei Patienten ab 2 Jahren

Packaging details

Description (FR)
FINTEPLA sol 2.2 mg/ml buvable fl 360 ml
Description (DE)
FINTEPLA Lös 2.2 mg/ml zum Einnehmen Fl 360 ml
Market launch
13/02/2025
Narcotic (BTM)
No

Other packaging sizes

FINTEPLA sol 2.2 mg/ml buvable fl 120 ml
120 ml FLAS
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