REBIF départ 6x8.8mcg + 6x22mcg ser pré 12 pce

7680548100603 CH-54810 L03AB07 01.99.0.

Active substances:

REBIF départ 6x8.8mcg + 6x22mcg ser pré 12 pce
REBIF départ 6x8.8mcg + 6x22mcg ser pré 12 pce
REBIF départ 6x8.8mcg + 6x22mcg ser pré 12 pce
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Details

Product number
5481004
CPT
-
Packaging group
6 + 6
Unit
Fertigspritze(n)
Composition
I) 8.8 mcg/0.2 ml: interferonum beta-1a ADNr 8.8 µg corresp. 2.4 Mio U.I., alcohol benzylicus 1.0 mg, mannitolum, methioninum, poloxamerum 188, natrii acetas trihydricus, natrii hydroxidum, acidum aceticum, aqua ad iniectabile q.s. ad solutionem pro 0.2 ml corresp. natrium 0.01 mg. II) 22 mcg/0.5 ml: interferonum beta-1a ADNr 22 µg corresp. 6 Mio U.I., alcohol benzylicus 2.5 mg, mannitolum, methioninum, poloxamerum 188, natrii acetas trihydricus, natrii hydroxidum, acidum aceticum, aqua ad iniectabile q.s. ad solutionem pro 0.5 ml corresp. natrium max. 0.03 mg.

Articles (1)

Rebif 8.8 und 22, Injektionslösung in Fertigspritzen
Injektionslösung
6 + 6
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
24/05/2024
Patient information leaflet
Français
24/05/2024
Patient information leaflet
Italien
24/05/2024
Professional SmPC
Allemand
24/05/2024
Professional SmPC
Français
24/05/2024
Professional SmPC
Italien
24/05/2024

Detailed composition

Substance Quantity Type Category
interferonum beta-1a ADNr
22.0 UG Substance Wirkstoff (Principe actif)
interferonum beta-1a ADNr
8.8 UG Substance Wirkstoff (Principe actif)
alcohol benzylicus
1.0 MG Substance HBESI
alcohol benzylicus
2.5 MG Substance HBESI
mannitolum
- Substance HNIDK
mannitolum
- Substance HNIDK
methioninum
- Substance ANTOX
methioninum
- Substance ANTOX
poloxamerum 188
- Substance HNIDK
poloxamerum 188
- Substance HNIDK
natrii acetas trihydricus
- Substance HNIDK
natrii acetas trihydricus
- Substance HNIDK
natrii hydroxidum
- Substance HNIDK
natrii hydroxidum
- Substance HNIDK
acidum aceticum
- Substance HNIDK
acidum aceticum
- Substance HNIDK
aqua ad iniectabile
- Substance GALEN
aqua ad iniectabile
- Substance GALEN
natrium
0.01 MG Substance HBESI
natrium
- Substance HBESI

Authorization holder

Merck (Schweiz) AG

6300 Zug

Authorization information

Swissmedic authorization number
54810
Drug name
Rebif, Injektionslösung in Fertigspritzen
Galenic form
LSPA
ATC Code
L03AB07
Authorization status
Z
Dispensation category
B
First authorization
23/12/1998
Authorization expiration date
31/12/9999
IT number
01.99.0.
Domain
Human medicine
Field of application
Multiple Sklerose

Packaging details

Description (FR)
REBIF départ 6x8.8mcg + 6x22mcg ser pré 12 pce
Description (DE)
REBIF Startpack 6x8.8mcg + 6x22mcg Fertspr 12 Stk
Market launch
10/10/2008
Narcotic (BTM)
No

Other packaging sizes

REBIF sol inj 22 mcg/0.5 ml ser pré 12 pce
12 FESP
View
REBIF sol inj 44 mcg/0.5 ml ser pré 12 pce
12 FESP
View
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