Sephience 1000 mg, Pulver zum Einnehmen

7680698100027 CH-69810 Pulver

Associated product:

SEPHIENCE pdr 1000 mg 30 pce

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Article details

Package size
30
Selling units
30
Measure
Beutel
Galenic form
Pulver
Galenic group
Lösbar zur Einnahme

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
23/08/2025
Patient information leaflet
Français
23/08/2025
Patient information leaflet
Italien
23/08/2025
Summary of Product Characteristics
Allemand
23/08/2025
Summary of Product Characteristics
Français
23/08/2025
Summary of Product Characteristics
Italien
23/08/2025

Detailed composition

Substance Quantity Type Category
sepiapterinum
1000.0 MG Substance Wirkstoff (Principe actif)
cellulosum microcristallinum
- Substance HNIDK
isomaltum
1600.0 MG Substance HBESI
mannitolum
- Substance HNIDK
carmellosum natricum conexum
- Substance HNIDK
natrium
- Substance HBESI
xanthani gummi
- Substance HNIDK
silica colloidalis anhydrica
- Substance HNIDK
sucralosum
- Substance HNIDK
magnesii stearas
- Substance HNIDK

Authorization holder

PTC Therapeutics Switzerland GmbH

6312 Steinhausen

Authorization information

Swissmedic authorization number
69810
Drug name
Sephience, Pulver zum Einnehmen im Beutel
Galenic form
PULOR
ATC Code
A16AX
Authorization status
Z
Dispensing category
B
First authorization
05/08/2025
Authorization expiration date
04/08/2030
IT Number
07.99.0.
Domain
Human medicine
Field of application
Behandlung von Hyperphenylalaninämie (HPA) bei pädiatrischen und erwachsenen Patienten mit Phenylketonurie (PKU), die nachweislich auf eine solche Behandlung ansprechen.

Package details

Description (FR)
SEPHIENCE pdr 1000 mg 30 pce
Description (DE)
SEPHIENCE Plv 1000 mg 30 Stk
Market launch
20/10/2025
Narcotic (BTM)
No

Other package sizes (1)

SEPHIENCE pdr 250 mg 30 pce
30 BEU
GTIN: 7680698100010
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