Potactasol

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topotecan

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Potactasol. 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 Potactasol.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Potactasol
Agency product number
EMEA/H/C/002282
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
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
7
Date of issue of marketing authorisation valid throughout the European Union
05/01/2011
Contact address
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

20/08/2018 Potactasol - EMEA/H/C/002282 - N/0017

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Topotecan monotherapy is indicated for the treatment of:

  • patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy
  • patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with thefirst-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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