Topotecan Actavis

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topotecan

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Topotecan Actavis has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 07/03/2019

Authorisation details

Product details
Name
Topotecan Actavis
Agency product number
EMEA/H/C/001031
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
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
Actavis Group PTC ehf
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
24/07/2009
Contact address
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland

Product information

15/01/2019 Topotecan Actavis - EMEA/H/C/001031 - IB/0013

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 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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