Ambrisentan OrPha 5 mg, Filmtabletten

7680675000012 CH-67500 Filmtabletten
Ambrisentan OrPha 5 mg, Filmtabletten
Ambrisentan OrPha 5 mg, Filmtabletten
Ambrisentan OrPha 5 mg, 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

Official medical documents

Summary of Product Characteristics
Allemand
11/11/2025
Summary of Product Characteristics
Français
11/11/2025
Summary of Product Characteristics
Italien
11/11/2025
Patient information leaflet
Allemand
17/08/2023
Patient information leaflet
Français
17/08/2023
Patient information leaflet
Italien
17/08/2023

Detailed composition

Substance Quantity Type Category
ambrisentanum
5.0 MG Substance Wirkstoff (Principe actif)
cellulosum microcristallinum
- Substance HNIDK
lactosum monohydricum
47.5 MG Substance HBESI
carmellosum natricum conexum
- Substance HNIDK
natrium
0.16 MG Substance HBESI
magnesii stearas
- Substance HNIDK
poly(alcohol vinylicus)
- Substance HNIDK
macrogolum 3350
- Substance HNIDK
talcum
- Substance HNIDK
E 129
0.022 MG Substance HBESI
lecithinum ex soja
- Substance HNIDK
E 171
- Substance FNIDK

Reimbursement information

Public price
CHF 898.75
Specialties list
Yes
Generic
Yes

Reimbursement limitation

SL addition date: 01/10/2023

Authorization holder

OrPha Swiss GmbH

8700 Küsnacht ZH

Authorization information

Swissmedic authorization number
67500
Drug name
Ambrisentan OrPha, Filmtabletten
Galenic form
FILM
ATC Code
C02KX02
Authorization status
Z
Dispensing category
B
First authorization
16/12/2022
Authorization expiration date
15/12/2027
IT Number
02.07.1.
Domain
Human medicine
Field of application
Pulmonale arterielle Hypertonie (PAH)

Package details

Description (FR)
AMBRISENTAN OrPha cpr pell 5 mg 30 cpr pell
Description (DE)
AMBRISENTAN OrPha Filmtabl 5 mg 30 Filmtabl
Market launch
16/12/2022
Narcotic (BTM)
No

Original drug

Volibris, Filmtabletten
GTIN: 7680586540010
CHF 1045.60
View original

Other package sizes (1)

AMBRISENTAN OrPha cpr pell 10 mg 30 cpr pell
30 TABL
GTIN: 7680675000029
View
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