Topotecan Hospira
topotecan
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
L01XX17
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
09/06/2010
|
Contact address |
Boulevard de la Plaine 17 |
Product information
01/08/2022 Topotecan Hospira - EMEA/H/C/001192 - IB/0048/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.