🇪🇺 Technetium Tc 99M Arcitumomab in European Union

EMA authorised Technetium Tc 99M Arcitumomab on 4 October 1996

Marketing authorisations

EMA — authorised 4 October 1996

  • Application: EMEA/H/C/000041
  • Marketing authorisation holder: Immunomedics GmbH
  • Local brand name: CEA-Scan
  • Indication: CEA-Scan is indicated only in patients with histologically-demonstrated carcinoma of the colon or rectum for imaging of recurrence and/or metastases. CEA-Scan is employed for diagnostic use only, 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, or Patients with suspected recurrence and/o
  • Status: withdrawn

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EMA — authorised 6 June 2001

  • Marketing authorisation holder: Amgen Europe B.V.
  • Status: approved

Technetium Tc 99M Arcitumomab in other countries

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

Other Oncology approved in European Union

Frequently asked questions

Is Technetium Tc 99M Arcitumomab approved in European Union?

Yes. EMA authorised it on 4 October 1996; EMA authorised it on 6 June 2001.

Who is the marketing authorisation holder for Technetium Tc 99M Arcitumomab in European Union?

Immunomedics GmbH holds the EU marketing authorisation.