Macitentan Spirig HC 10 mg, Filmtabletten

7680703710012 CH-70371 Filmtabletten

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Article details

Package size
30
Selling units
30
Measure
Tablette(n)
Galenic form
Filmtabletten
Galenic group
Tabletten

Official Swissmedic V2 data

Additional information from the official database

Detailed composition

Substance Quantity Type Category
macitentanum
10.0 MG Substance Wirkstoff (Principe actif)
maltodextrinum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
mannitolum
- Substance HNIDK
amylum pregelificatum
- Substance HNIDK
carmellosum natricum conexum
- Substance HNIDK
magnesii stearas
- Substance HNIDK
poly(alcohol vinylicus)
- Substance HNIDK
talcum
- Substance HNIDK
glyceroli monocaprylocapras
- Substance HNIDK
natrii laurilsulfas
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
E 171
- Substance FNIDK
natrium
0.1807 MG Substance HBESI

Authorization holder

Spirig HealthCare AG

4622 Egerkingen

Authorization information

Swissmedic authorization number
70371
Drug name
Macitentan Spirig HC, Filmtabletten
Galenic form
FILM
ATC Code
C02KX04
Authorization status
Z
Dispensing category
B
First authorization
07/05/2026
Authorization expiration date
06/05/2031
IT Number
02.07.1.
Domain
Human medicine
Field of application
Pulmonale arterielle Hypertonie

Package details

Description (FR)
MACITENTAN Spirig HC cpr pellic 10 mg 30 pce
Description (DE)
MACITENTAN Spirig HC Filmtabl 10 mg 30 Stk
Market launch
04/12/2026
Narcotic (BTM)
No
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