Indimacis 125

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Withdrawn

This medicine's authorisation has been withdrawn

igovomab
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Indimacis 125 has been withdrawn at the request of the marketing authorisation holder.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
Indimacis 125
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

Pharmacotherapeutic group

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.

Authorisation details

EMA product number
EMEA/H/C/000065
Marketing authorisation holder
CIS bio international

B.P. 32
91192 Gif-sur-Yvette Cedex
France

Marketing authorisation issued
04/10/1996
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