SAI - Detailed view

TYSABRI Inf Konz 300 mg/15ml Fl 15 ml

Drug

Name

Tysabri 300 mg, Konzentrat zur Herstellung einer Infusionslösung

Field of application

Multiple Sklerose

ATC

L04AA23 - NATALIZUMAB

01.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

KOINF – Concentrate for solution for infusion

Remedy code

BT – biological medicines

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

57273

Initial registration date

5/3/2007

Expiry date

12/31/9999

Dosage strength

Name

Tysabri 300 mg, Konzentrat zur Herstellung einer Infusionslösung

Field of application

Multiple Sklerose

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680572730012

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

1 vial(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

300 mg natalizumabum

Excipient

natrii dihydrogenophosphas monohydricus
dinatrii phosphas heptahydricus
natrii chloridum
polysorbatum 80
aqua ad iniectabile
52 mg natrium

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

1700.05

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

7/4/2024

Information for prof.

Leaflet

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