Qalsody, Injektionslösung zur intrathekalen Anwendung

7680685770011 CH-68577 Injektionslösung

Associated product:

QALSODY sol inj 6.7 mg/ml 1 pce

No image available

Article details

Package size
1
Selling units
1
Measure
Durchstechflasche(n)
Galenic form
Injektionslösung
Galenic group
Injektion/Infusion

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
10/07/2026
Patient information leaflet
Français
10/07/2026
Patient information leaflet
Italien
10/07/2026
Summary of Product Characteristics
Allemand
10/07/2026
Summary of Product Characteristics
Français
10/07/2026
Summary of Product Characteristics
Italien
10/07/2026

Detailed composition

Substance Quantity Type Category
tofersenum
- Substance Wirkstoff (Principe actif)
tofersenum natricum
- Substance WIZUS
natrii dihydrogenophosphas dihydricus
- Substance HNIDK
dinatrii phosphas
- Substance HNIDK
natrii chloridum
- Substance HNIDK
kalii chloridum
- Substance HNIDK
calcii chloridum dihydricum
- Substance HNIDK
magnesii chloridum hexahydricum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
- Substance HBESI
kalium
- Substance HBESI

Authorization holder

Biogen Switzerland AG

6340 Baar

Authorization information

Swissmedic authorization number
68577
Drug name
Qalsody, Injektionslösung zur intrathekalen Anwendung
Galenic form
LSINJ
ATC Code
N07XX22
Authorization status
B
Dispensing category
A
First authorization
19/12/2025
Authorization expiration date
18/12/2027
IT Number
01.99.0.
Domain
Human medicine
Field of application
Qalsody ist indiziert für die Behandlung der amyotrophen Lateralsklerose (ALS) im Zusammenhang mit einer Mutation im Superoxiddismutase-1-Gen (SOD1)

Package details

Description (FR)
QALSODY sol inj 6.7 mg/ml 1 pce
Description (DE)
QALSODY Inj Lös 6.7 mg/ml 1 Stk
Market launch
01/07/2026
Narcotic (BTM)
No

Application methods

ITHE
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