- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 23 July 2021 the European Commission withdrew the marketing authorisation for Lumoxiti (moxetumomab pasudotox) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Lumoxiti was granted marketing authorisation in the EU on 8 February 2021 for treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU.
The European Public Assessment Report (EPAR) for Lumoxiti is updated to indicate that the marketing authorisation is no longer valid.
Lumoxiti : EPAR - Medicine overview
English (EN) (724.73 KB - PDF)
български (BG) (815.81 KB - PDF)
español (ES) (722.86 KB - PDF)
čeština (CS) (793.79 KB - PDF)
dansk (DA) (721.03 KB - PDF)
Deutsch (DE) (1.29 MB - PDF)
eesti keel (ET) (715.6 KB - PDF)
ελληνικά (EL) (819.77 KB - PDF)
français (FR) (725.87 KB - PDF)
hrvatski (HR) (746.79 KB - PDF)
italiano (IT) (1.28 MB - PDF)
latviešu valoda (LV) (805.12 KB - PDF)
lietuvių kalba (LT) (746.92 KB - PDF)
magyar (HU) (793.41 KB - PDF)
Malti (MT) (797.91 KB - PDF)
Nederlands (NL) (721.98 KB - PDF)
polski (PL) (795.38 KB - PDF)
português (PT) (723.86 KB - PDF)
română (RO) (746.19 KB - PDF)
slovenčina (SK) (794 KB - PDF)
slovenščina (SL) (793.45 KB - PDF)
Suomi (FI) (719.9 KB - PDF)
svenska (SV) (720.85 KB - PDF)
Lumoxiti : EPAR - Risk-management-plan summary
English (EN) (754.84 KB - PDF)
Product information
Lumoxiti : EPAR - Product information
English (EN) (1016.76 KB - PDF)
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)
ελληνικά (EL) (1.91 MB - PDF)
français (FR) (1 MB - PDF)
hrvatski (HR) (798.78 KB - PDF)
íslenska (IS) (975.57 KB - PDF)
italiano (IT) (952.21 KB - PDF)
latviešu valoda (LV) (1.55 MB - PDF)
lietuvių kalba (LT) (836.52 KB - PDF)
magyar (HU) (1.53 MB - PDF)
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)
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)
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 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
English (EN) (922.17 KB - PDF)
Lumoxiti : EPAR - Public assessment report
English (EN) (6.14 MB - PDF)
CHMP summary of positive opinion for Lumoxiti
English (EN) (737.82 KB - PDF)
News on Lumoxiti
More information on Lumoxiti
This product was originallydesignated 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.