Overview
The marketing authorisation for Topotecan Actavis has been withdrawn at the request of the marketing-authorisation holder.
Topotecan Actavis : EPAR - Summary for the public
Product information
Topotecan Actavis : EPAR - Product Information
Latest procedure affecting product information: IB/0013
15/01/2019
This medicine’s product information is available in all official EU languages.
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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).
Topotecan Actavis : EPAR - All Authorised presentations
Product details
- Name of medicine
- Topotecan Actavis
- 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
- L01CE01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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
Topotecan Actavis : EPAR - Procedural steps taken and scientific information after authorisation