Lumoxiti
Withdrawn
This medicine's authorisation has been withdrawn
moxetumomab pasudotox
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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The marketing authorisation for Lumoxiti has been withdrawn at the request of the marketing-authorisation holder.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
English (EN) (724.73 KB - PDF)
First published: Last updated:
български (BG) (815.81 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
español (ES) (722.86 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
čeština (CS) (793.79 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
dansk (DA) (721.03 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Deutsch (DE) (1.29 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
eesti keel (ET) (715.6 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
ελληνικά (EL) (819.77 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
français (FR) (725.87 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
hrvatski (HR) (746.79 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
italiano (IT) (1.28 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
latviešu valoda (LV) (805.12 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
lietuvių kalba (LT) (746.92 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
magyar (HU) (793.41 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Malti (MT) (797.91 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Nederlands (NL) (721.98 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
polski (PL) (795.38 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
português (PT) (723.86 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
română (RO) (746.19 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
slovenčina (SK) (794 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
slovenščina (SL) (793.45 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Suomi (FI) (719.9 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
svenska (SV) (720.85 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Lumoxiti : EPAR - Risk-management-plan summary
English (EN) (754.84 KB - PDF)
First published: Last updated:
Product information
Lumoxiti : EPAR - Product information
English (EN) (1016.76 KB - PDF)
First published: Last updated:
български (BG) (1.82 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
español (ES) (959.63 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
čeština (CS) (1.5 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
dansk (DA) (973.12 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Deutsch (DE) (1011.13 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
eesti keel (ET) (951 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
ελληνικά (EL) (1.91 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
français (FR) (1 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
hrvatski (HR) (798.78 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
íslenska (IS) (975.57 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
italiano (IT) (952.21 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
latviešu valoda (LV) (1.55 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
lietuvių kalba (LT) (836.52 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
magyar (HU) (1.53 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Malti (MT) (894.3 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Nederlands (NL) (966.08 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
norsk (NO) (977.84 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
polski (PL) (1.56 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
português (PT) (1.01 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
română (RO) (818.55 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
slovenčina (SK) (1.52 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
slovenščina (SL) (1.47 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Suomi (FI) (813.39 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
svenska (SV) (971.85 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
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
English (EN) (599.6 KB - PDF)
First published: Last updated:
български (BG) (1.18 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
español (ES) (602.88 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
čeština (CS) (616.51 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
dansk (DA) (624.71 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Deutsch (DE) (602.32 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
eesti keel (ET) (601.63 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
ελληνικά (EL) (621.92 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
français (FR) (599.55 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
hrvatski (HR) (1.14 MB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
íslenska (IS) (618.09 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
italiano (IT) (597.58 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
latviešu valoda (LV) (612.93 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
lietuvių kalba (LT) (594.59 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
magyar (HU) (615.51 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Malti (MT) (620.58 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Nederlands (NL) (598.96 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
norsk (NO) (627.26 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
polski (PL) (619.32 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
português (PT) (595.43 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
română (RO) (603.25 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
slovenčina (SK) (616.54 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
slovenščina (SL) (615.72 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
Suomi (FI) (621.52 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
svenska (SV) (625.74 KB - PDF)
First published: 09/03/2021Last updated: 11/08/2021
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 agentsTherapeutic 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
AdoptedReference Number: EMADOC-1700519818-608352
English (EN) (922.17 KB - PDF)
First published: Last updated:
Lumoxiti : EPAR - Public assessment report
AdoptedReference Number: EMA/CHMP/36661/2021
English (EN) (6.14 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Lumoxiti
AdoptedReference Number: EMA/CHMP/652159/2020
English (EN) (737.82 KB - PDF)
First published: Last updated:
News on Lumoxiti
More information on Lumoxiti
Public statement on Lumoxiti : Withdrawal of the marketing authorisation in the European Union
AdoptedReference Number: EMA/431204/2021
English (EN) (112.29 KB - PDF)
First published:
This product was originally designated an orphan medicine on 5 December 2008. Lumoxiti was withdrawn from the Community register of orphan medicinal products by the European Commission in July 2021 at the time of the withdrawal of the marketing authorisation.
This page was last updated on