Spinraza 12mg/5ml, Injektionslösung zur intrathekalen Injektion

7680664950014 CH-66495 Injektionslösung
Spinraza 12mg/5ml, Injektionslösung zur intrathekalen Injektion
Spinraza 12mg/5ml, Injektionslösung zur intrathekalen Injektion
Spinraza 12mg/5ml, Injektionslösung zur intrathekalen Injektion
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Article details

Package size
5 ml
Selling units
5
Measure
Durchstechflasche(n)
Galenic form
Injektionslösung
Galenic group
Injektion/Infusion

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Summary of Product Characteristics
Allemand
12/05/2026
Summary of Product Characteristics
Français
12/05/2026
Summary of Product Characteristics
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
12.0 MG Substance Wirkstoff (Principe actif)
nusinersenum natricum
12.6 MG 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 72153.05
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/07/2020

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
Dispensing 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)

Package details

Description (FR)
SPINRAZA sol inj 12 mg/5ml flac
Description (DE)
SPINRAZA Inj Lös 12 mg/5ml Durchstf
Market launch
20/09/2017
Narcotic (BTM)
No

Application methods

ITHE

Other package sizes (2)

SPINRAZA 28mg/5ml sol inj 28 mg 5ml pce
5 ml DUR
GTIN: 7680664950021
View
SPINRAZA 50mg/5ml sol inj 50 mg 5ml pce
5 ml DUR
GTIN: 7680664950038
View
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