Topotecan Hospira

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topotecan

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Topotecan Hospira. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Topotecan Hospira.

This EPAR was last updated on 30/10/2020

Authorisation details

Product details
Name
Topotecan Hospira
Agency product number
EMEA/H/C/001192
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
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
09/06/2010
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

07/10/2020 Topotecan Hospira - EMEA/H/C/001192 - N/0038

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

Other 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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