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SAI - Detailed view
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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
nusinersenum natricum
natrii dihydrogenophosphas dihydricus
dinatrii phosphas
natrii chloridum
kalii chloridum
calcii chloridum dihydricum
magnesii chloridum hexahydricum
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile
dinatrii phosphas
natrii chloridum
kalii chloridum
calcii chloridum dihydricum
magnesii chloridum hexahydricum
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile
Spezialitätenliste***
GGSL
-
-
80736.10
None
Yes
10%
No
Authorisation holder
7601001326217
Biogen Switzerland AG
Neuhofstrasse 30
6340 Baar (ZG)
Neuhofstrasse 30
6340 Baar (ZG)
Date of revision of the text
7/4/2024
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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.