Lumoxiti
moxetumomab pasudotox
Table of contents
Overview
The marketing authorisation for Lumoxiti has been withdrawn at the request of the marketing-authorisation holder.
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List item
Lumoxiti : EPAR - Medicine overview (PDF/724.73 KB)
First published: 09/03/2021
Last updated: 11/08/2021
EMA/691967/2020 -
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Lumoxiti : EPAR - Risk-management-plan summary (PDF/754.84 KB)
First published: 09/03/2021
Last updated: 11/08/2021
Authorisation details
| Product details | |
|---|---|
| Name |
Lumoxiti
|
| Agency product number |
EMEA/H/C/005322
|
| Active substance |
Moxetumomab pasudotox
|
| International non-proprietary name (INN) or common name |
moxetumomab pasudotox
|
| Therapeutic area (MeSH) |
Leukemia, Hairy Cell
|
| Anatomical therapeutic chemical (ATC) code |
L01X
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
AstraZeneca AB
|
| Date of issue of marketing authorisation valid throughout the European Union |
08/02/2021
|
| Contact address |
AstraZeneca AB |
Product information
23/07/2021 Lumoxiti - EMEA/H/C/005322 -
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Antineoplastic agents
Therapeutic indication
Lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (PNA).