Takhzyro

RSS

lanadelumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Takhzyro is a medicine used to prevent attacks of hereditary angioedema in patients aged 2 years and over.

Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs. Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway.

Hereditary angioedema is rare, and Takhzyro was designated an 'orphan medicine' (a medicine used in rare diseases) on 9 October 2015. Further information on the orphan designation can be found here.

Takhzyro contains the active substance lanadelumab.

This EPAR was last updated on 22/11/2023

Authorisation details

Product details
Name
Takhzyro
Agency product number
EMEA/H/C/004806
Active substance
lanadelumab
International non-proprietary name (INN) or common name
lanadelumab
Therapeutic area (MeSH)
Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code
B06AC05
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Takeda Pharmaceuticals International AG Ireland Branch
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
22/11/2018
Contact address

Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Co Dublin
D02 HW68
Ireland

Product information

15/11/2023 Takhzyro - EMEA/H/C/004806 - X/0034/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other hematological agents

Therapeutic indication

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.

Assessment history

Related content

How useful was this page?

Add your rating
Average
1 rating
3 ratings