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

7680695880021 CH-69588 L04AL03 07.15.0.

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Details

Product number
6958802
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
nipocalimabum 1200 mg, histidinum, histidini hydrochloridum monohydricum, arginini hydrochloridum, saccharum, methioninum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 6.5 ml.

Articles (1)

Imaavy 1200 mg/6.5 ml (185 mg/ml), Konzentrat zur Herstellung einer Infusionslösung
Konzentrat
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
21/01/2026
Professional SmPC
Français
21/01/2026
Professional SmPC
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
Dispensation 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.

Packaging 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 packaging sizes

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