Orkambi 100 mg / 125 mg, Filmtabletten

7680659810026 CH-65981 Filmtabletten
Orkambi 100 mg / 125 mg, Filmtabletten
Orkambi 100 mg / 125 mg, Filmtabletten
Orkambi 100 mg / 125 mg, Filmtabletten
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Article details

Package size
112 (4 x 28)
Selling units
3136
Measure
Tablette(n)
Galenic form
Filmtabletten
Galenic group
Tabletten

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
21/08/2026
Patient information leaflet
Français
21/08/2026
Patient information leaflet
Italien
21/08/2026
Summary of Product Characteristics
Allemand
21/08/2026
Summary of Product Characteristics
Français
21/08/2026
Summary of Product Characteristics
Italien
21/08/2026

Detailed composition

Substance Quantity Type Category
lumacaftorum
100.0 MG Substance Wirkstoff (Principe actif)
ivacaftorum
125.0 MG Substance Wirkstoff (Principe actif)
hypromellosi acetas succinas
- Substance HNIDK
natrii laurilsulfas
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
cellulosum microcristallinum
- Substance HNIDK
carmellosum natricum conexum
- Substance HNIDK
povidonum K 30
- Substance HNIDK
magnesii stearas
- Substance HNIDK
poly(alcohol vinylicus)
- Substance HNIDK
macrogolum 3350
- Substance HNIDK
talcum
- Substance HNIDK
E 120
- Substance FIMDK
E 132
- Substance FIMDK
E 133
- Substance FIMDK
E 171
- Substance FNIDK
lacca
- Substance HNIDK
E 172 (nigrum)
- Substance FTODK
propylenglycolum
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
ammonii hydroxidum
- Substance HNIDK
natrium
2.56 MG Substance HBESI

Reimbursement information

Public price
CHF 10080.10
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/05/2020

Authorization holder

Vertex Pharmaceuticals (CH) GmbH

6300 Zug

Authorization information

Swissmedic authorization number
65981
Drug name
Orkambi, Filmtabletten
Galenic form
FILM
ATC Code
R07AX30
Authorization status
Z
Dispensing category
A
First authorization
02/09/2016
Authorization expiration date
31/12/9999
IT Number
03.99.0.
Domain
Human medicine
Field of application
Mukoviszidose

Package details

Description (FR)
ORKAMBI 100mg/125mg cpr pell 112 pce
Description (DE)
ORKAMBI 100mg/125mg Filmtabl 112 Stk
Market launch
19/04/2018
Narcotic (BTM)
No

Other package sizes (1)

ORKAMBI 200mg/125mg cpr pell 112 pce
112 (4 x 28) TABL
GTIN: 7680659810019
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