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The marketing authorisation for HumaSPECT has not been renewed by the marketing authorisation holder and is now withdrawn.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