AMBRISENTAN OrPha cpr pell 10 mg 30 pce

7680675000029 CH-67500 C02KX02 02.07.1.

Reimbursement limitations:

VOLIBRIS

Traitement de l’hypertension artérielle pulmonaire idiopathique (HTAPI) et de l’HTAP associée à des affections de …

AMBRISENTAN OrPha cpr pell 10 mg 30 pce
AMBRISENTAN OrPha cpr pell 10 mg 30 pce
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Details

Product number
6750002
CPT
-
Packaging group
30
Unit
Tablette(n)
Composition
ambrisentanum 10 mg, cellulosum microcristallinum, lactosum monohydricum 95.0 mg, carmellosum natricum conexum corresp. natrium 0.35 mg, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, E 129 0.405 mg, lecithinum ex soja, E 171, pro compresso obducto.

Articles (1)

Ambrisentan OrPha 10 mg, Filmtabletten
Filmtabletten
30
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
17/08/2023
Patient information leaflet
Français
17/08/2023
Patient information leaflet
Italien
17/08/2023
Professional SmPC
Allemand
17/08/2023
Professional SmPC
Français
17/08/2023
Professional SmPC
Italien
17/08/2023

Detailed composition

Substance Quantity Type Category
(N/A)
10.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
95.0 MG Substance HBESI
(N/A)
- Substance HNIDK
(N/A)
0.35 MG Substance HBESI
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
0.405 MG Substance HBESI
(N/A)
- Substance HNIDK
(N/A)
- Substance FNIDK

Reimbursement information

Public price
CHF 1093.70
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
Dispensation 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)

Packaging details

Description (FR)
AMBRISENTAN OrPha cpr pell 10 mg 30 pce
Description (DE)
AMBRISENTAN OrPha Filmtabl 10 mg 30 Stk
Market launch
16/12/2022
Narcotic (BTM)
No

Original drug

Volibris, Filmtabletten
CHF 1195.35
View original

Other packaging sizes

AMBRISENTAN OrPha cpr pell 5 mg 30 pce
30 TABL
View