Topotecan Eagle

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topotecan

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Topotecan Eagle has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/11/2014

Authorisation details

Product details
Name
Topotecan Eagle
Agency product number
EMEA/H/C/002261
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
L01XX17
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Eagle Laboratories Ltd.   
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
22/12/2011
Contact address
Eagle Laboratories Ltd.
c/o Pink Accounting Resources Ltd
The Clockhouse, Station Approach
Marlow, Bucks SL7 1NT
United Kingdom

Product information

02/10/2014 Topotecan Eagle - EMEA/H/C/002261 - IB/0001

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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