Bosentan Spirig HC 62.5 mg, Filmtabletten

7680697900017 CH-69790 Filmtabletten

Associated product:

BOSENTAN Spirig HC cpr pellic 62.5 mg 56 pce

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Article details

Package size
56
Selling units
56
Measure
Tablette(n)
Galenic form
Filmtabletten
Galenic group
Tabletten

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
24/12/2025
Patient information leaflet
Français
24/12/2025
Patient information leaflet
Italien
24/12/2025
Summary of Product Characteristics
Allemand
24/12/2025
Summary of Product Characteristics
Français
24/12/2025
Summary of Product Characteristics
Italien
24/12/2025

Detailed composition

Substance Quantity Type Category
bosentanum
62.5 MG Substance Wirkstoff (Principe actif)
bosentanum monohydricum
64.54 MG Substance WIZUS
cellulosum microcristallinum
- Substance HNIDK
carboxymethylamylum natricum A
- Substance HNIDK
natrium
- Substance HBESI
povidonum K 30
- Substance HNIDK
magnesii stearas
- Substance HNIDK
hypromellosum
- Substance HNIDK
triacetinum
- Substance HNIDK
talcum
- Substance HNIDK
E 171
- Substance FNIDK
E 172 (rubrum)
- Substance FTODK
E 172 (flavum)
- Substance FTODK

Reimbursement information

Public price
CHF 743.70
Specialties list
Yes
Generic
Yes
SL addition date: 01/01/2026

Authorization holder

Spirig HealthCare AG

4622 Egerkingen

Authorization information

Swissmedic authorization number
69790
Drug name
Bosentan Spirig HC, Filmtabletten
Galenic form
FILM
ATC Code
C02KX01
Authorization status
Z
Dispensing category
B
First authorization
21/10/2025
Authorization expiration date
20/10/2030
IT Number
02.07.1.
Domain
Human medicine
Field of application
Pulmonale arterielle Hypertonie (PAH) bei Patienten der WHO-Funktionsklasse II-IV. Reduktion der Anzahl neuer digitaler Ulzerationen bei Patienten mit systemischer Sklerose mit aktiver digitaler Ulzerationserkrankung.

Package details

Description (FR)
BOSENTAN Spirig HC cpr pellic 62.5 mg 56 pce
Description (DE)
BOSENTAN Spirig HC Filmtabl 62.5 mg 56 Stk
Market launch
24/02/2026
Narcotic (BTM)
No

Original drug

Tracleer, Filmtabletten
GTIN: 7680558410013
CHF 800.80
View original

Other package sizes (1)

BOSENTAN Spirig HC cpr pellic 125 mg 56 pce
56 TABL
GTIN: 7680697900024
View
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