🇪🇺 VOTUMUMAB in European Union

EMA authorised VOTUMUMAB on 25 September 1998

Marketing authorisation

EMA — authorised 25 September 1998

  • Application: EMEA/H/C/000145
  • Marketing authorisation holder: KS Biomedix Limited
  • Local brand name: HumaSPECT
  • 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 ther
  • Status: withdrawn

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VOTUMUMAB in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is VOTUMUMAB approved in European Union?

Yes. EMA authorised it on 25 September 1998.

Who is the marketing authorisation holder for VOTUMUMAB in European Union?

KS Biomedix Limited holds the EU marketing authorisation.