SPINRAZA 50mg/5ml sol inj 50 mg 5ml pce

7680664950038 CH-66495 M09AX 01.99.0.

Active substances:

Nusinersenum

No images available

Details

Product number
6649503
CPT
-
Packaging group
5 ml
Unit
Durchstechflasche(n)
Composition
nusinersenum 50 mg ut nusinersenum natricum, natrii dihydrogenophosphas dihydricus, dinatrii phosphas, natrii chloridum, kalii chloridum, calcii chloridum dihydricum, magnesii chloridum hexahydricum, natrii hydroxidum ad pH, acidum hydrochloridum ad pH, aqua ad iniectabile q.s. ad solutionem pro 5 ml corresp. natrium max. 19.2 mg et kalium 0.59 mg.

Articles (1)

Spinraza 50mg/5ml, Injektionslösung zur intrathekalen Injektion
Injektionslösung
5 ml
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
12/05/2026
Professional SmPC
Français
12/05/2026
Professional SmPC
Italien
12/05/2026
Patient information leaflet
Allemand
05/03/2026
Patient information leaflet
Français
05/03/2026
Patient information leaflet
Italien
05/03/2026

Detailed composition

Substance Quantity Type Category
nusinersenum
50.0 MG Substance Wirkstoff (Principe actif)
nusinersenum 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
natrii hydroxidum
- Substance HNIDK
acidum hydrochloridum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
- Substance HBESI
kalium
0.59 MG Substance HBESI

Reimbursement information

Public price
CHF 140068.90
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/07/2026

Authorization holder

Biogen Switzerland AG

6340 Baar

Authorization information

Swissmedic authorization number
66495
Drug name
Spinraza, Injektionslösung
Galenic form
LSINJ
ATC Code
M09AX
Authorization status
Z
Dispensation category
A
First authorization
20/09/2017
Authorization expiration date
31/12/9999
IT number
01.99.0.
Domain
Human medicine
Field of application
Behandlung der 5q-assoziierten spinalen Muskelatrophie (SMA)

Packaging details

Description (FR)
SPINRAZA 50mg/5ml sol inj 50 mg 5ml pce
Description (DE)
SPINRAZA 50mg/5ml Inj Lös 50 mg 5ml Stk
Market launch
01/06/2026
Narcotic (BTM)
No

Other packaging sizes

SPINRAZA sol inj 12 mg/5ml flac
5 ml DUR
GTIN: 7680664950014
View
SPINRAZA 28mg/5ml sol inj 28 mg 5ml pce
5 ml DUR
GTIN: 7680664950021
View
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