Topotecan Hospira



This medicine is authorised for use in the European Union.


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 04/08/2022

Authorisation details

Product details
Topotecan Hospira
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Uterine Cervical Neoplasms
  • Small Cell Lung Carcinoma
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Boulevard de la Plaine 17
1050 Bruxelles

Product information

01/08/2022 Topotecan Hospira - EMEA/H/C/001192 - IB/0048/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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