Topotecan Eagle

Withdrawn

This medicine's authorisation has been withdrawn

topotecan

Overview

On 2 October 2014, the European Commission withdrew the marketing authorisation for Topotecan Eagle (topotecan) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Eagle Laboratories Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Topotecan Eagle was granted marketing authorisation in the EU on 22 December 2011 for the treatment of patients with relapsed small cell lung cancer when re-treatment with the first-line regimen is not considered appropriate. It was also approved for the treatment of women with cancer of the cervix in combination with cisplatin when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix). The marketing authorisation was initially valid for a 5-year period. 

Topotecan Eagle is a ‘hybrid generic medicine’ of Hycamtin. There are other generic medicinal products of Hycamtin authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Topotecan Eagle is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Topotecan Eagle : EPAR - Summary for the public

Reference Number: EMEA/H/C/002261

Product information

Topotecan Eagle : EPAR - Product Information

Topotecan Eagle : EPAR - All Authorised presentations

Topotecan Eagle : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Topotecan Eagle
• Active substance:
  topotecan hydrochloride
• International non-proprietary name (INN) or common name:
  topotecan
• Therapeutic area (MeSH):
  • Carcinoma
  • Small Cell Lung Carcinoma
• Anatomical therapeutic chemical (ATC) code:
  L01CE01

Pharmacotherapeutic group

Antineoplastic and immunomodulating agents

Therapeutic indication

Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

Authorisation details

• EMA product number:
  EMEA/H/C/002261
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Eagle Laboratories Ltd.

  Eagle Laboratories Ltd. ; c/o Pink Accounting Resources Ltd; The Clockhouse, Station Approach; Marlow, Bucks SL7 1NT; United Kingdom

• Marketing authorisation issued:
  22/12/2011
• Withdrawal of marketing authorisation:
  02/10/2014
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Topotecan Eagle : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Topotecan Eagle : EPAR - Public assessment report

Adopted Reference Number: EMA/1352/2012

CHMP summary of positive opinion for Topotecan Eagle

Adopted Reference Number: EMA/CHMP/795162/2011