ASPAVELI sol perf 1080 mg/20ml flac 20 ml

7680686740013 CH-68674 L04AJ03 07.15.0.

Active substances:

ASPAVELI sol perf 1080 mg/20ml flac 20 ml
ASPAVELI sol perf 1080 mg/20ml flac 20 ml
ASPAVELI sol perf 1080 mg/20ml flac 20 ml
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Details

GTIN
7680686740013
Pharmacode
-
Product number
6867401
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
pegcetacoplanum 54 mg, sorbitolum 41 mg, acidum aceticum glaciale, natrii acetas trihydricus, natrii hydroxidum, acidum aceticum glaciale, aqua ad iniectabile, ad solutionem pro 1 ml corresp. natrium 0.37 mg.

Articles (1)

Aspaveli, Infusionslösung
Infusionslösung
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
18/08/2026
Professional SmPC
Français
18/08/2026
Professional SmPC
Italien
18/08/2026
Patient information leaflet
Allemand
17/08/2026
Patient information leaflet
Français
17/08/2026
Patient information leaflet
Italien
17/08/2026

Detailed composition

Substance Quantity Type Category
pegcetacoplanum
54.0 MG Substance Wirkstoff (Principe actif)
sorbitolum
41.0 MG Substance HBESI
acidum aceticum glaciale
- Substance HNIDK
natrii acetas trihydricus
- Substance HNIDK
natrii hydroxidum
- Substance HNIDK
acidum aceticum glaciale
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
0.37 MG Substance HBESI

Reimbursement information

Public price
CHF 2958.95
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/06/2023

Authorization holder

Swedish Orphan Biovitrum AG

4058 Basel

Authorization information

Swissmedic authorization number
68674
Drug name
Aspaveli, Infusionslösung
Galenic form
LSINF
ATC Code
L04AJ03
Authorization status
Z
Dispensation category
A
First authorization
23/03/2023
Authorization expiration date
22/03/2028
IT number
07.15.0.
Domain
Human medicine
Field of application
Als Monotherapie für die Behandlung erwachsener Patienten mit paroxysmaler nächtlicher Hämoglobinurie (PNH), welche eine hämolytische Anämie aufweisen. Behandlung von erwachsenen und jugendlichen Patienten im Alter von 12 bis 17 Jahren mit C3-Glomerulopathie (C3G) oder primärer Immunkomplex-vermittelter membranoproliferativer Glomerulonephritis (IC-MPGN).

Packaging details

Description (FR)
ASPAVELI sol perf 1080 mg/20ml flac 20 ml
Description (DE)
ASPAVELI Inf Lös 1080 mg/20ml Durchstf 20 ml
Market launch
23/03/2023
Narcotic (BTM)
No

Other packaging sizes

ASPAVELI sol perf 1080 mg/20ml 8 flac 20 ml
8 DUR
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