Takhzyro

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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 12 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.

Takhzyro contains the active substance lanadelumab.

Hereditary angioedema is rare, and Takhzyro was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 October 2015. 

This EPAR was last updated on 01/10/2019

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.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Shire Pharmaceuticals Ireland Ltd
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/11/2018
Contact address

Block 2-3, Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 Y754 
Ireland

Product information

14/03/2019 Takhzyro - EMEA/H/C/004806 - IB/0001/G

Contents

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Pharmacotherapeutic group

Other hematological agents

Therapeutic indication

Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

Assessment history

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