BOSENTAN Spirig HC cpr pellic 62.5 mg 56 pce

7680697900017 CH-69790 C02KX01 02.07.1.

Active substances:

Bosentanum

Reimbursement limitations:

AMGEVITA-5

Substitution préparation de référence/biosimilaire Le traitement par AMGEVITA exige une garantie préalable de prise en …

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Details

Product number
6979001
CPT
-
Packaging group
56
Unit
Tablette(n)
Composition
Filmtablette: bosentanum 62.5 mg ut bosentanum monohydricum 64.54 mg, cellulosum microcristallinum, carboxymethylamylum natricum A corresp. natrium max. 0.16 mg, povidonum K 30, magnesii stearas, Überzug: hypromellosum, triacetinum, talcum, E 171, E 172 (rubrum), E 172 (flavum), pro compresso obducto.

Articles (1)

Bosentan Spirig HC 62.5 mg, Filmtabletten
Filmtabletten
56
View

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
Professional SmPC
Allemand
24/12/2025
Professional SmPC
Français
24/12/2025
Professional SmPC
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
Dispensation 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.

Packaging 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 packaging sizes

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