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SAI - Detailed view

SPINRAZA Inj Lös 12 mg/5ml Durchstf

Drug

Spinraza, Injektionslösung
Behandlung der 5q-assoziierten spinalen Muskelatrophie (SMA)
01.99.0. – various

HAM – Human medicine
LSPA – Parenteral solution
S – synthetic products for human use
A – Dispensed once only on prescription by a physician or veterinarian (A)

Z – approved
9/20/2017
12/31/9999

Dosage strength

Spinraza 12mg/5ml, Lösung zur intrathekalen Injektion
Behandlung der 5q-assoziierten spinalen Muskelatrophie (SMA)
01
Z – approved

Package

7680664950014
No information made available
A/R – Authorised / referenced 

5 ml vial(s)
ITHE – Intrathecal use

001
Z – approved

Declaration

Component Solvent

12 mg nusinersenum
nusinersenum natricum
natrii dihydrogenophosphas dihydricus
dinatrii phosphas
natrii chloridum
kalii chloridum
calcii chloridum dihydricum
magnesii chloridum hexahydricum
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile

Spezialitätenliste***

GGSL
-
-
80674.55
None
Yes
10%
No

Authorisation holder

7601001326217
Biogen Switzerland AG
Neuhofstrasse 30
6340 Baar (ZG)

Date of revision of the text

1/4/2024

Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.