Lumoxiti

Withdrawn

This medicine's authorisation has been withdrawn

moxetumomab pasudotox

Overview

The marketing authorisation for Lumoxiti has been withdrawn at the request of the marketing-authorisation holder.

Lumoxiti : EPAR - Medicine overview

Reference Number: EMA/691967/2020

Lumoxiti : EPAR - Risk-management-plan summary

Product information

Lumoxiti : EPAR - Product information

23/07/2021

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).

Lumoxiti : EPAR - All authorised presentations

Product details

• Name of medicine:
  Lumoxiti
• 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

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).

Authorisation details

• EMA product number:
  EMEA/H/C/005322
• Marketing authorisation holder:
  AstraZeneca AB

  SE-151 85 Sodertalje; Sweden

• Opinion adopted:
  10/12/2020
• Marketing authorisation issued:
  08/02/2021

Assessment history

Initial marketing authorisation documents

Lumoxiti : Orphan maintenance assessment report

AdoptedReference Number: EMADOC-1700519818-608352

Lumoxiti : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/36661/2021

CHMP summary of positive opinion for Lumoxiti

AdoptedReference Number: EMA/CHMP/652159/2020