Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1814048
|
Name of medicinal product:
|
TAKHZYRO
|
Active substances:
|
|
ATC code:
|
B06AC05
|
Dosage form:
|
solution for injection
|
Route of administration:
|
subcutaneous use
|
Strengh:
|
300mg 2ml
|
Amount in package:
|
2ml 6TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE)
in patients aged 2 years and older.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Takeda Pharmaceuticals International AG Ireland Branch
|
Marketing authorization number:
|
EU/1/18/1340
|
Marketing authorization issued on:
|
November 22, 2018
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
November 24, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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