SEPHIENCE pdr 250 mg 30 pce

7680698100010 CH-69810 A16AX 07.99.0.

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Details

Product number
6981001
CPT
-
Packaging group
30
Unit
Beutel
Composition
sepiapterinum 250 mg, cellulosum microcristallinum, isomaltum 400 mg, mannitolum, carmellosum natricum conexum corresp. natrium max. 0.9 mg, xanthani gummi, silica colloidalis anhydrica, sucralosum, magnesii stearas, pro charta.

Articles (1)

Sephience 250 mg, Pulver zum Einnehmen
Pulver
30
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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
Professional SmPC
Allemand
23/08/2025
Professional SmPC
Français
23/08/2025
Professional SmPC
Italien
23/08/2025

Detailed composition

Substance Quantity Type Category
sepiapterinum
250.0 MG Substance Wirkstoff (Principe actif)
cellulosum microcristallinum
- Substance HNIDK
isomaltum
400.0 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
Dispensation 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.

Packaging details

Description (FR)
SEPHIENCE pdr 250 mg 30 pce
Description (DE)
SEPHIENCE Plv 250 mg 30 Stk
Market launch
20/10/2025
Narcotic (BTM)
No

Other packaging sizes

SEPHIENCE pdr 1000 mg 30 pce
30 BEU
GTIN: 7680698100027
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