DepoCyte

Withdrawn

This medicine's authorisation has been withdrawn

cytarabine

Overview

The marketing authorisation for DepoCyte has been withdrawn at the request of the marketing authorisation holder. 

DepoCyte : EPAR - Summary for the public

Product information

DepoCyte : EPAR - 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).

DepoCyte : EPAR - All Authorised presentations

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 agents

Therapeutic indication

Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.

Authorisation details

• EMA product number:
  EMEA/H/C/000317
• Marketing authorisation holder:
  Pacira Limited

  3 Glory Park Avenue; Wooburn Green; High Wycombe; Buckinghamshire; HP10 0DF; United Kingdom

• Opinion adopted:
  10/07/2018
• Marketing authorisation issued:
  11/07/2001
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

DepoCyte : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

DepoCyte : EPAR - Scientific Discussion

DepoCyte : EPAR - Procedural steps taken before authorisation