Adzynma 500 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung

7680695620016 CH-69562 Pulver

Associated product:

ADZYNMA 500 I.E. subst seche 1x500 ml

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Article details

Package size
1 x 500
Selling units
500
Measure
I.E.
Galenic form
Pulver
Galenic group
Lösbar zur Einnahme

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
19/03/2026
Patient information leaflet
Français
19/03/2026
Patient information leaflet
Italien
19/03/2026
Summary of Product Characteristics
Allemand
19/03/2026
Summary of Product Characteristics
Français
19/03/2026
Summary of Product Characteristics
Italien
19/03/2026

Detailed composition

Substance Quantity Type Category
rADAMTS13
500.0 UIML Substance Wirkstoff (Principe actif)
aqua ad iniectabile
- Substance HNIDK
natrii chloridum
- Substance HNIDK
natrium
3.7 MG Substance HBESI
calcii chloridum dihydricum
- Substance HNIDK
histidinum
- Substance HNIDK
mannitolum
- Substance HNIDK
saccharum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK

Authorization holder

Takeda Pharma AG

8152 Opfikon

Authorization information

Swissmedic authorization number
69562
Drug name
Adzynma, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Galenic form
PULMJ
ATC Code
B01AD13
Authorization status
Z
Dispensing category
B
First authorization
24/02/2026
Authorization expiration date
23/02/2031
IT Number
06.99.0.
Domain
Human medicine
Field of application
Enzymersatztherapie bei ADAMTS-13 Mangel bei Kindern und Erwachsenen mit kongenitaler thrombotisch-thrombozytopenischer Purpura

Package details

Description (FR)
ADZYNMA 500 I.E. subst seche 1x500 ml
Description (DE)
ADZYNMA 500 I.E. Trockensub 1x500 ml
Market launch
13/03/2026
Narcotic (BTM)
No

Other package sizes (1)

ADZYNMA 1500 I.E. subst seche 1500 U.I. 1x1500 ml
1 x 1500 IE
GTIN: 7680695620023
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