Overview

The marketing authorisation for HumaSPECT has not been renewed by the marketing authorisation holder and is now withdrawn.

Product information

24/09/2003

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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
HumaSPECT
Active substance
votumumab
International non-proprietary name (INN) or common name
votumumab
Therapeutic area (MeSH)
  • Ultrasonography
  • Colorectal Neoplasms
  • Tomography, X-Ray Computed
Anatomical therapeutic chemical (ATC) code
V09IX

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

After reconstitution with sodium pertechnetate [99mTc] solution, HumaSPECT [99mTc] is indicated in patients with histologically proven carcinoma of the colon or rectum for imaging of recurrence and/or metastases. HumaSPECT [99mTc] is employed, in the above mentioned patients, as an adjunct to standard non invasive imaging techniques, such as ultrasonography or CT scan, in the following situations.
• Patients with evidence of recurrence and/or metastatic carcinoma of the colon or rectum, who are undergoing an evaluation for extent of disease, such as prior to surgical resection and/or other therapy.
• Patients with suspected recurrence and/or metastatic carcinoma of the colon or rectum in association with rising levels of carcinoembryonic antigen (CEA).

Authorisation details

EMA product number
EMEA/H/C/000145
Marketing authorisation holder
KS Biomedix Limited

KS Biomedix
Unit 7, Romans Business Park
East Street
Farnham, Surrey GU9 7SX
United Kingdom

Marketing authorisation issued
25/09/1998
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