Indimacis 125

RSS

igovomab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Indimacis 125 has been withdrawn at the request of the marketing authorisation holder.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
Indimacis 125
Agency product number
EMEA/H/C/000065
Active substance
igovomab
International non-proprietary name (INN) or common name
igovomab
Therapeutic area (MeSH)
  • Radionuclide Imaging
  • Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
V09IB03
Publication details
Marketing-authorisation holder
CIS bio international
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
04/10/1996
Contact address
B.P. 32
91192 Gif-sur-Yvette Cedex
France

Product information

31/12/2009 Indimacis 125 - EMEA/H/C/000065 -

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

V09 Diagnostic radiopharmaceuticals

Therapeutic indication

Positive diagnosis of relapsing ovarian adenocarcinoma when serum CA 125 is increased without positive results of ultrasound or computerised tomography scan.

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