Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1827367
Name of medicinal product: TAKHZYRO
Active substances:
Lanadelumab
Estonian, English, Latin
ATC code: B06AC05
Dosage form: solution for injection in pre-filled syringe
Route of administration: subcutaneous use
Strengh: 300mg 2ml
Amount in package: 2ml 1TK
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 12 years and older.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: June 30, 2022
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
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: November 26, 2023 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 26, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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