SAI - Detailed view

Taltz 80 mg, solution injectable en seringue préremplie 2

Drug

Name

Taltz, solution injectable en seringue préremplie

Field of application

Plaque-Psoriasis bei Erwachsenen, Psoriasis-Arthritis, Plaque-Psoriasis bei Kindern und Jugendlichen ab 6 Jahren mit einem Körpergewicht von mindestens 25 kg, Ankylosierende Spondylitis, Nicht-radiographische axiale Spondyloarthritis

ATC

L04AC13 - IXEKIZUMAB

07.15.0. – immunosuppressants

Use

HAM – Human medicine

pharmaceutical form

INLFS – Solution for injection in pre-filled syringe

Remedy code

BT – biological medicines

Dispensing categories

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

Authorisation status

Z – approved

Authorisation number

65906

Initial registration date

12/12/2016

Expiry date

12/31/9999

Dosage strength

Name

Taltz 80 mg, solution injectable en seringue préremplie

Field of application

Psoriasis en plaques chez l'adulte, Arthrite psoriasique, Psoriasis en plaques chez l'enfant et l'adolescent à partir de 6 ans et d'un poids corporel d'au moins 25 kg, Spondylarthrite ankylosante, Spondyloarthrite axiale non radiographique

Dosage strength number

Authorisation status

Z – approved

Package

Trade status*

No information made available

Status

NA – No longer authorised

Package size

2 pre-filled syringe(s)

Package code

004

Authorisation status

D – no longer approved

Expiry date

11/8/2024

Declaration

Component

Active substance

80 mg ixekizumabum
80 mg ixekizumabum

Excipient

natrii citras dihydricus
saccharum
acidum citricum
polysorbatum 80
natrii chloridum
natrii hydroxidum
polysorbatum 80
aqua ad iniectabile
aqua ad iniectabile
5.8 mg natrium

Authorisation holder

GLN**

7601001261853

Address

Eli Lilly (Suisse) SA
chemin des Coquelicots 16
580
1214 Vernier (GE)

Date of revision of the text

12/1/2024

Information for prof.

Leaflet

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