Topotecan Actavis
topotecan
Table of contents
Overview
The marketing authorisation for Topotecan Actavis has been withdrawn at the request of the marketing-authorisation holder.
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) |
|
| Anatomical therapeutic chemical (ATC) code |
L01XX17
|
Generic |
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
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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.