SAI - Detailed view

ENBREL MyClic Inj Lös 50 mg/ml 2 Fertpen 1 ml

Drug

Name

Enbrel MyClic, Injektionslösung im Fertigpen

Field of application

Rheumatoide Arthritis, aktive juvenile idiopatische Arthritis (Polyarthritis, Oligoarthritis, Psoriasis-Arthritis, Enthesitis-assoziierte Arthritis), Psoriasis-Arthritis, Morbus Bechterew (ankylosierende Spondylitis), mittelschwere bis schwere Plaque-Psoriasis

ATC

L04AB01 - ETANERCEPT

07.15.0. – immunosuppressants

Use

HAM – Human medicine

pharmaceutical form

LSPA – Parenteral solution

Remedy code

BT – biological medicines

Dispensing categories

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

Authorisation status

Z – approved

Authorisation number

60025

Initial registration date

5/31/2010

Expiry date

12/31/9999

Dosage strength

Name

Enbrel MyClic 50 mg, Injektionslösung im Fertigpen

Field of application

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680600250024

Trade status*

In trade from / since 5/31/2010

Status

A/R – Authorised / referenced

Package size

2 set

Package code

002

Authorisation status

Z – approved

Declaration

Component Solution

Active substance

50 mg etanerceptum

Excipient

arginini hydrochloridum
natrii chloridum
saccharum
dinatrii phosphas dihydricus
natrii dihydrogenophosphas dihydricus
aqua ad iniectabile
2.97 mg natrium

Component Wipe with

Excipient

alcohol isopropylicus

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

455.15

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001010604

Address

Pfizer AG
Schärenmoosstrasse 99
8052 Zürich (ZH)

Date of revision of the text

6/1/2025

Information for prof.

Leaflet

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