Topotecan Actavis

Withdrawn

This medicine's authorisation has been withdrawn

topotecan

Overview

On 15 January 2019, the European Commission withdrew the marketing authorisation for Topotecan Actavis (topotecan) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Actavis Group PTC ehf, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Topotecan Actavis was granted marketing authorisation in the EU on 24 July 2009 for treatment of small-cell lung cancer and carcinoma of the cervix. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. The product had not been marketed in the EU since 2017. Topotecan Actavis is a 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Report (EPAR) for Topotecan Actavis is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Topotecan Actavis : EPAR - Summary for the public

Product information

Topotecan Actavis : EPAR - Product Information

Topotecan Actavis : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Antineoplastic 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/001031
• 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:
  Actavis Group PTC ehf

  Dalshraun 1; 220 Hafnarfjörður; Iceland

• Marketing authorisation issued:
  24/07/2009
• Withdrawal of marketing authorisation:
  15/01/2019
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Topotecan Actavis : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Topotecan Actavis

Reference Number: EMEA/CHMP/291093/2009