Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
TAKHZYRO
|
Active substances:
|
|
ATC code:
|
B06AC05
|
Dosage form:
|
solution for injection in pre-filled syringe
|
Strength:
|
300mg 2ml
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Indication:
|
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE)
in patients aged 2 years and older.
|
Safety features:
|
Yes
|
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
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1827367
|
TAKHZYRO
|
solution for injection in pre-filled syringe
|
300mg 2ml 2ml 1TK
|
Prescription
|
|
|
14.03.2024
|
|
|
3046395
|
TAKHZYRO
|
solution for injection in pre-filled syringe
|
300mg 2ml 2ml 2TK
|
Prescription
|
|
|
|
|
|
3046407
|
TAKHZYRO
|
solution for injection in pre-filled syringe
|
300mg 2ml 2ml 6TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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