Takhzyro
lanadelumab
Table of contents
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.
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 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 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. |
Orphan |
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 |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
22/11/2018
|
Contact address |
Block 2-3, Miesian Plaza |
Product information
24/07/2020 Takhzyro - EMEA/H/C/004806 - IB/0016
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.