Evotopin

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Withdrawn

This medicine's authorisation has been withdrawn

topotecan
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Evotopin has been withdrawn at the request of the marketing authorisation holder.

Product information

31/12/2009
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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).

Product details

Name of medicine
Evotopin
Active substance
topotecan
International non-proprietary name (INN) or common name
topotecan
Therapeutic area (MeSH)
Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01CE01

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.

Authorisation details

EMA product number
EMEA/H/C/000124
Marketing authorisation holder
Beecham Group plc

,
Great West Road
Brentford, Middlesex, TW8 9BD
United Kingdom

Marketing authorisation issued
15/04/1997
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