← Drug database

HumaSPECT (votumumab)

Region

🇪🇺 EU

Active substance

votumumab

Company

KS Biomedix Limited

Status

Withdrawn

Therapeutic area

Ultrasonography; Colorectal Neoplasms; Tomography, X-Ray Computed

EU approval

Fri 25 Sep 1998

Application

EMEA/H/C/000145

ATC

V09IX

Official record

www.ema.europa.eu

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).

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.