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SAI - Detailed view

OPSUMIT Filmtabl 10 mg 30 Stk

Drug

Opsumit, Filmtabletten
Pulmonale arterielle Hypertonie
02.07.1. – simple antihypertensives

HAM – Human medicine
FILM – Film-coated tablet
S – synthetic products for human use
B – Dispensed on prescription by a physician or veterinarian (B)

Z – approved
2/6/2014
12/31/9999

Dosage strength

Opsumit 10 mg, Filmtabletten
Pulmonale arterielle Hypertonie
01
Z – approved

Package

7680618630016
In trade from / since 2/6/2014
A/R – Authorised / referenced 

30 tablet(s)

001
Z – approved

Declaration

Component Film-coated tablet

10 mg macitentanum
38.86 mg lactosum monohydricum
cellulosum microcristallinum
carboxymethylamylum natricum A
0.21 mg natrium
povidonum K 30
magnesii stearas
polysorbatum 80
poly(alcohol vinylicus)
talcum
lecithinum ex soja
xanthani gummi
E 171

Spezialitätenliste***

SL
-
-
3062.65
None
Yes
10%
No

Authorisation holder

7601001345225
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16
4123 Allschwil (BL)

Date of revision of the text

4/29/2025

Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.