Topotecan Teva

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topotecan

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 13/07/2018

Authorisation details

Product details
Name
Topotecan Teva
Agency product number
EMEA/H/C/001071
Active substance
topotecan
International non-proprietary name (INN) or common name
topotecan
Therapeutic area (MeSH)
  • Ovarian Neoplasms
  • Uterine Cervical Neoplasms
  • 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
Teva B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
21/09/2009
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

22/06/2018 Topotecan Teva - EMEA/H/C/001071 - IB/0014

Contents

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 agents

Therapeutic indication

Topotecan monotherapy is indicated for the treatment of:

  • patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;
  • 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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