Lumoxiti
Withdrawn
This medicine's authorisation has been withdrawn
moxetumomab pasudotox
Medicine
Human
Withdrawn
- 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The European Public Assessment Report (EPAR) for Lumoxiti is updated to indicate that the marketing authorisation is no longer valid.
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).
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).
News on Lumoxiti
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