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 | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
16
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Date of issue of marketing authorisation valid throughout the European Union |
09/06/2010
|
Contact address |
Product information
09/02/2021 Topotecan Hospira - EMEA/H/C/001192 - IA/0042
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
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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.