Imaavy 1200 mg/6.5 ml (185 mg/ml), Konzentrat zur Herstellung einer Infusionslösung

7680695880021 CH-69588 Konzentrat

Associated product:

IMAAVY 1200 mg/6.5 ml (185 mg/ml) conc perf 1200 m

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Article details

Package size
1
Selling units
1
Measure
Durchstechflasche(n)
Galenic form
Konzentrat
Galenic group
Tinkturen/Desinfektion

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Summary of Product Characteristics
Allemand
21/01/2026
Summary of Product Characteristics
Français
21/01/2026
Summary of Product Characteristics
Italien
21/01/2026

Detailed composition

Substance Quantity Type Category
nipocalimabum
1200.0 MG Substance Wirkstoff (Principe actif)
histidinum
- Substance HNIDK
histidini hydrochloridum monohydricum
- Substance HNIDK
arginini hydrochloridum
- Substance HNIDK
saccharum
- Substance HNIDK
methioninum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK

Authorization holder

Janssen-Cilag AG

6300 Zug

Authorization information

Swissmedic authorization number
69588
Drug name
Imaavy, Konzentrat zur Herstellung einer Infusionslösung
Galenic form
KOINF
ATC Code
L04AL03
Authorization status
Z
Dispensing category
A
First authorization
18/12/2025
Authorization expiration date
17/12/2030
IT Number
07.15.0.
Domain
Human medicine
Field of application
Als Zusatzbehandlung zur Standardtherapie der generalisierten Myasthenia gravis (gMG) bei Patienten ab 12 Jahren, die Anti-Acetylcholin-Rezeptor (AChR)- oder Anti-Muskelspezifische Tyrosinkinase (MuSK)-Antikörper-positiv sind.

Package details

Description (FR)
IMAAVY 1200 mg/6.5 ml (185 mg/ml) conc perf 1200 m
Description (DE)
IMAAVY 1200 mg/6.5 ml (185 mg/ml) Konz Inf 1200 mg
Market launch
02/03/2026
Narcotic (BTM)
No

Other package sizes (1)

IMAAVY 300 mg/1.62 ml (185 mg/ml) conc perf 300 mg
1 DUR
GTIN: 7680695880014
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