MabCampath
Withdrawn
This medicine's authorisation has been withdrawn
alemtuzumab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 6 July 2001 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product MabCampath (alemtuzumab) for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate.
The marketing authorisation holder (MAH) responsible for MabCampath was Genzyme Europe B.V. The European Commission was notified by letter of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for MabCampath for commercial reasons.
On 8 August 2012 the European Commission issued a decision to withdraw the marketing authorisation for MabCampath. The MAH has committed to ensure that patients who need treatment with MabCampath for B-CLL and some other transplant/oncology indications will continue to receive it through patient access programmes. Details of these programmes are being discussed at national level and will be governed by national competent authorities.
Pursuant to this decision the European Public Assessment Report for MabCampath is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0055
06/07/2001
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
- MabCampath
- Active substance
- alemtuzumab
- International non-proprietary name (INN) or common name
- alemtuzumab
- Therapeutic area (MeSH)
- Leukemia, Lymphocytic, Chronic, B-Cell
- Anatomical therapeutic chemical (ATC) code
- L01XC04
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.
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