Overview

The marketing authorisation for Lumoxiti has been withdrawn at the request of the marketing-authorisation holder.

Lumoxiti : EPAR - Medicine overview

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svenska (SV) (720.85 KB - PDF)

Lumoxiti : EPAR - Risk-management-plan summary

Product information

Lumoxiti : EPAR - Product information

български (BG) (1.82 MB - PDF)
español (ES) (959.63 KB - PDF)
čeština (CS) (1.5 MB - PDF)
dansk (DA) (973.12 KB - PDF)
Deutsch (DE) (1011.13 KB - PDF)
eesti keel (ET) (951 KB - PDF)
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hrvatski (HR) (798.78 KB - PDF)
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latviešu valoda (LV) (1.55 MB - PDF)
lietuvių kalba (LT) (836.52 KB - PDF)
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Malti (MT) (894.3 KB - PDF)
Nederlands (NL) (966.08 KB - PDF)
norsk (NO) (977.84 KB - PDF)
polski (PL) (1.56 MB - PDF)
português (PT) (1.01 MB - PDF)
română (RO) (818.55 KB - PDF)
slovenčina (SK) (1.52 MB - PDF)
slovenščina (SL) (1.47 MB - PDF)
Suomi (FI) (813.39 KB - PDF)
svenska (SV) (971.85 KB - PDF)

23/07/2021

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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

български (BG) (1.18 MB - PDF)
español (ES) (602.88 KB - PDF)
čeština (CS) (616.51 KB - PDF)
dansk (DA) (624.71 KB - PDF)
Deutsch (DE) (602.32 KB - PDF)
eesti keel (ET) (601.63 KB - PDF)
ελληνικά (EL) (621.92 KB - PDF)
français (FR) (599.55 KB - PDF)
hrvatski (HR) (1.14 MB - PDF)
íslenska (IS) (618.09 KB - PDF)
italiano (IT) (597.58 KB - PDF)
latviešu valoda (LV) (612.93 KB - PDF)
lietuvių kalba (LT) (594.59 KB - PDF)
magyar (HU) (615.51 KB - PDF)
Malti (MT) (620.58 KB - PDF)
Nederlands (NL) (598.96 KB - PDF)
norsk (NO) (627.26 KB - PDF)
polski (PL) (619.32 KB - PDF)
português (PT) (595.43 KB - PDF)
română (RO) (603.25 KB - PDF)
slovenčina (SK) (616.54 KB - PDF)
slovenščina (SL) (615.72 KB - PDF)
Suomi (FI) (621.52 KB - PDF)
svenska (SV) (625.74 KB - PDF)

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

Lumoxiti : Orphan maintenance assessment report

Lumoxiti : EPAR - Public assessment report

CHMP summary of positive opinion for Lumoxiti

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