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The marketing authorisation for Lumoxiti has been withdrawn at the request of the marketing-authorisation holder.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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slovenščina (SL)
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svenska (SV)
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Lumoxiti : EPAR - Risk-management-plan summary
English (EN)
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Product information
Lumoxiti : EPAR - Product information
English (EN)
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български (BG)
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español (ES)
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Deutsch (DE)
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eesti keel (ET)
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ελληνικά (EL)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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norsk (NO)
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polski (PL)
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português (PT)
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română (RO)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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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)View
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)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
(615.51 KB - PDF)
Malti (MT)
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Nederlands (NL)
(598.96 KB - PDF)
norsk (NO)
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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).
Assessment history
This page was last updated on