Evotopin

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topotecan

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Evotopin has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 31/12/2009

Authorisation details

Product details
Name
Evotopin
Agency product number
EMEA/H/C/000124
Active substance
topotecan
International non-proprietary name (INN) or common name
topotecan
Therapeutic area (MeSH)
Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XX17
Publication details
Marketing-authorisation holder
Beecham Group plc
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
15/04/1997
Contact address
,
Great West Road
Brentford, Middlesex, TW8 9BD
United Kingdom

Product information

31/12/2009 Evotopin - EMEA/H/C/000124 -

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 is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

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