SAI - Detailed view

SPINRAZA Inj Lös 12 mg/5ml Durchstf

Drug

Name

Spinraza, Injektionslösung

Field of application

Behandlung der 5q-assoziierten spinalen Muskelatrophie (SMA)

ATC

M09AX - OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM

01.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

LSINJ – Solution for injection

Remedy code

TGT – transplant product: gene therapy product

Dispensing categories

A – Dispensed once only on prescription by a physician or veterinarian (A)

Authorisation status

Z – approved

Authorisation number

66495

Initial registration date

9/20/2017

Expiry date

12/31/9999

Dosage strength

Name

Spinraza 12mg/5ml, Injektionslösung zur intrathekalen Injektion

Field of application

Behandlung der 5q-assoziierten spinalen Muskelatrophie (SMA)

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680664950014

Trade status*

In trade from / since 9/20/2017

Status

A/R – Authorised / referenced

Package size

5 ml vial(s)

Application type

ITHE – Intrathecal use

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

12 mg nusinersenum
12.6 mg nusinersenum natricum

Excipient

natrii dihydrogenophosphas dihydricus
dinatrii phosphas
natrii chloridum
kalii chloridum
calcii chloridum dihydricum
magnesii chloridum hexahydricum
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile
max. 18.17 mg natrium
0.59 mg kalium

Spezialitätenliste***

Status

GGSL

Date of deletion

Compulsory until

Public price (CHF)

72603.15

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001326217

Address

Biogen Switzerland AG
Neuhofstrasse 30
6340 Baar (ZG)

Date of revision of the text

3/1/2026

Information for prof.

Leaflet

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