Lumoxiti

RSS

moxetumomab pasudotox

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Lumoxiti has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 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
Sodertalje
SE-151 85 Sodertalje
Sweden

Product information

23/07/2021 Lumoxiti - EMEA/H/C/005322 -

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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

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).

Assessment history

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