SAI - Detailed view

ORENCIA Inj Lös 125 mg/ml Fertpen 4 x 1 ml

Drug

Name

Orencia, Injektionslösung zur subkutanen Anwendung (Fertigpen)

Field of application

Rheumatoide Arthritis

ATC

L04AA24 - ABATACEPT

07.15.0. – immunosuppressants

Use

HAM – Human medicine

pharmaceutical form

SUPA – Parenteral suspension

Remedy code

BT – biological medicines

Dispensing categories

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

Authorisation status

Z – approved

Authorisation number

65833

Initial registration date

3/15/2016

Expiry date

12/31/9999

Dosage strength

Name

Orencia 125 mg/1 ml, Injektionslösung zur subkutanen Anwendung (Fertigpen)

Field of application

Rheumatoide Arthritis

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680658330013

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

4 prefilled pen(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

125 mg abataceptum

Excipient

saccharum
poloxamerum 188
natrii dihydrogenophosphas monohydricus
dinatrii phosphas
aqua ad iniectabile
0.32 mg natrium

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

1044.75

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001010703

Address

Bristol-Myers Squibb SA
Hinterbergstrasse 16
6312 Steinhausen (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.