Eprex 8000 U, Injektionslösung (Fertigspritzen)

7680490788140 Pharmacode 3948633 CH-49078 B03XA01 06.07.3.
Eprex 8000 U, Injektionslösung (Fertigspritzen)
Eprex 8000 U, Injektionslösung (Fertigspritzen)
Eprex 8000 U, Injektionslösung (Fertigspritzen)
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Details

GTIN
7680490788140
Pharmacode
3948633
Product number
4907841
CPT
-
Packaging group
6 x 0,8 mL
Unit
Spritze(n)
Composition
epoetinum alfa 8000 U.I., polysorbatum 80, natrii chloridum, natrii dihydrogenophosphas dihydricus, dinatrii phosphas dihydricus, glycinum, aqua ad iniectabile q.s. ad solutionem pro 0.8 ml corresp. natrium 2.466 mg.

Articles (1)

Eprex 8000 U, Injektionslösung (Fertigspritzen)
Injektionslösung
6 x 0,8 mL
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
27/01/2022
Patient information leaflet
Français
27/01/2022
Patient information leaflet
Italien
27/01/2022
Professional SmPC
Allemand
27/01/2022
Professional SmPC
Français
27/01/2022
Professional SmPC
Italien
27/01/2022

Detailed composition

Substance Quantity Type Category
epoetinum alfa
8000.0 UI Substance Wirkstoff (Principe actif)
polysorbatum 80
- Substance HNIDK
natrii chloridum
- Substance HNIDK
natrii dihydrogenophosphas dihydricus
- Substance HNIDK
dinatrii phosphas dihydricus
- Substance HNIDK
glycinum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
2.466 MG Substance HBESI

Authorization holder

Janssen-Cilag AG

6300 Zug

Authorization information

Swissmedic authorization number
49078
Drug name
Eprex, Injektionslösung
Galenic form
INLFS
ATC Code
B03XA01
Authorization status
Z
Dispensation category
A
First authorization
27/07/1988
Authorization expiration date
31/12/9999
IT number
06.07.3.
Domain
Human medicine
Field of application
Stimulierung der Erythropoese

Packaging details

Description (FR)
EPREX 8000 U sol inj 6x0,8mL ml
Description (DE)
EPREX 8000 U Inj Lös 6x0,8mL ml
Market launch
06/06/2007
Narcotic (BTM)
No

Other packaging sizes

EPREX 1000 UI/0.5ml (Protecs) 6 ser pré 0.5 ml
6 x 0,5 mL SPRI
View
EPREX 2000 UI/0.5ml (Protecs) 6 ser pré 0.5 ml
6 x 0,5 mL SPRI
View
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