HumaSPECT
Withdrawn
This medicine's authorisation has been withdrawn
votumumab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 25 September 1998, the European Commission granted a marketing authorisation for HumaSPECT (votumumab) for the whole European Union to Organon Teknika. The marketing authorisation was subsequently transferred to KS Biomedix Ltd. HumaSPECT is indicated in patients with histologically proven carcinoma of the colon or rectum for imaging of recurrence and/or metastases.
HumaSPECT is not marketed anywhere in the world. On 22 September 2003, KS Biomedix Ltd notified the European Commission of its decision not to renew the marketing authorisation for HumaSPECT for commercial reasons. Alternatives are available in Europe, since other radiopharmaceutical agents are used for this indication.
On 24 September 2003, the marketing authorisation for HumaSPECT expired. Consequently, the European Public Assessment Report for HumaSPECT has been removed from this website.
Product information
24/09/2003
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
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