AMBRISENTAN OrPha cpr pell 5 mg 30 pce

7680675000012 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 5 mg 30 pce
AMBRISENTAN OrPha cpr pell 5 mg 30 pce
AMBRISENTAN OrPha cpr pell 5 mg 30 pce
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Details

Product number
6750001
CPT
-
Packaging group
30
Unit
Tablette(n)
Composition
ambrisentanum 5 mg, cellulosum microcristallinum, lactosum monohydricum 47.5 mg, carmellosum natricum conexum corresp. natrium 0.16 mg, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, E 129 0.022 mg, lecithinum ex soja, E 171, pro compresso obducto.

Articles (1)

Ambrisentan OrPha 5 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)
5.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
47.5 MG Substance HBESI
(N/A)
- Substance HNIDK
(N/A)
0.16 MG Substance HBESI
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
0.022 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 5 mg 30 pce
Description (DE)
AMBRISENTAN OrPha Filmtabl 5 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 10 mg 30 pce
30 TABL
View