🇪🇺 Samarium 153 in European Union

EMA authorised Samarium 153 on 4 February 1998

Marketing authorisation

EMA — authorised 4 February 1998

  • Application: EMEA/H/C/000150
  • Marketing authorisation holder: CIS bio international
  • Local brand name: Quadramet
  • Indication: Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan. The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.
  • Status: approved

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Samarium 153 in other countries

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

Frequently asked questions

Is Samarium 153 approved in European Union?

Yes. EMA authorised it on 4 February 1998.

Who is the marketing authorisation holder for Samarium 153 in European Union?

CIS bio international holds the EU marketing authorisation.