BYLVAY 200 µg caps 200 µg 30 pce

7680696000015 CH-69600 A05AX05 04.99.0.

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Details

Product number
6960001
CPT
-
Packaging group
30
Unit
Kapsel(n)
Composition
odevixibatum 200 µg, odevixibatum sesquihydricum, cellulosum microcristallinum, hypromellosum, Kapselhülle: hypromellosum, E 171, E 172 (flavum), Drucktinte: lacca, propylenglycolum, E 172 (nigrum), pro capsula.

Articles (1)

Bylvay 200 μg, Hartkapseln
Kapseln
30
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
19/12/2025
Patient information leaflet
Français
19/12/2025
Patient information leaflet
Italien
19/12/2025
Professional SmPC
Allemand
19/12/2025
Professional SmPC
Français
19/12/2025
Professional SmPC
Italien
19/12/2025

Detailed composition

Substance Quantity Type Category
odevixibatum
200.0 UG Substance Wirkstoff (Principe actif)
odevixibatum sesquihydricum
- Substance WIZUS
cellulosum microcristallinum
- Substance HNIDK
hypromellosum
- Substance HNIDK
hypromellosum
- Substance HNIDK
E 171
- Substance FNIDK
E 172 (flavum)
- Substance FTODK
lacca
- Substance HNIDK
propylenglycolum
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
E 172 (nigrum)
- Substance FTODK

Authorization holder

IPSEN Pharma Schweiz GmbH

6300 Zug

Authorization information

Swissmedic authorization number
69600
Drug name
Bylvay, Hartkapseln
Galenic form
KAHA
ATC Code
A05AX05
Authorization status
Z
Dispensation category
B
First authorization
04/12/2025
Authorization expiration date
03/12/2030
IT number
04.99.0.
Domain
Human medicine
Field of application
Behandlung von cholestatischem Pruritus bei Patienten mit progressiver familiärer intrahepatischer Cholestase (PFIC) und bei Patienten mit Alagille-Syndrom (ALGS)

Packaging details

Description (FR)
BYLVAY 200 µg caps 200 µg 30 pce
Description (DE)
BYLVAY 200 µg Kaps 200 µg 30 Stk
Market launch
01/04/2026
Narcotic (BTM)
No

Other packaging sizes

BYLVAY 400 µg caps 400 µg 30 pce
30 KAP
GTIN: 7680696000022
View
BYLVAY 600 µg caps 600 µg 30 pce
30 KAP
GTIN: 7680696000039
View
BYLVAY 1200 µg caps 1.2 mg 30 pce
30 KAP
GTIN: 7680696000046
View
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