SPINRAZA sol inj 12 mg/5ml flac

7680664950014 CH-66495 M09AX 01.99.0.

Reimbursement limitations:

SPINRAZA2

SPINRAZA ne peut être prescrit et administré que par un spécialiste en neurologie ou en …

SPINRAZA sol inj 12 mg/5ml flac
SPINRAZA sol inj 12 mg/5ml flac
SPINRAZA sol inj 12 mg/5ml flac
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Details

Product number
6649501
CPT
-
Packaging group
5 ml
Unit
Durchstechflasche(n)
Composition
Solvens: nusinersenum 12 mg ut nusinersenum natricum, natrii dihydrogenophosphas dihydricus, dinatrii phosphas, natrii chloridum, kalii chloridum, calcii chloridum dihydricum, magnesii chloridum hexahydricum, natrii hydroxidum, acidum hydrochloridum, aqua ad iniectabile q.s. ad solutionem pro 5 ml.

Articles (1)

Spinraza 12mg/5ml, Lösung zur intrathekalen Injektion
Lösung
5 ml
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
11/10/2025
Professional SmPC
Français
11/10/2025
Professional SmPC
Italien
11/10/2025
Patient information leaflet
Allemand
07/02/2024
Patient information leaflet
Français
07/02/2024
Patient information leaflet
Italien
07/02/2024

Detailed composition

Substance Quantity Type Category
SOLV
12.0 MG Substance Wirkstoff (Principe actif)
SOLV
- Substance WIZUS
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK
SOLV
- Substance HNIDK

Reimbursement information

Public price
CHF 80736.10
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
LSPA
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 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