DepoCyte
Withdrawn
This medicine's authorisation has been withdrawn
cytarabine
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 10 July 2018, the European Commission withdrew the marketing authorisation for DepoCyte (cytarabine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pacira Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
DepoCyte was granted marketing authorisation in the EU on 11 July 2001 for the intrathecal treatment of lymphomatous meningitis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2011.
The European Public Assessment Report (EPAR) for DepoCyte is updated to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0059
26/06/2017
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
- DepoCyte
- Active substance
- cytarabine
- International non-proprietary name (INN) or common name
- cytarabine
- Therapeutic area (MeSH)
- Meningeal Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01BC01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.
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