🇪🇺 AB1010 in European Union

EMA authorised AB1010 on 22 November 2013

Marketing authorisations

EMA — authorised 22 November 2013

  • Application: EMEA/H/C/002670
  • Marketing authorisation holder: AB Science
  • Local brand name: Masican
  • Indication: Treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST)
  • Pathway: orphan
  • Status: rejected

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EMA — authorised 23 January 2014

  • Application: EMEA/H/C/002659
  • Marketing authorisation holder: AB Science
  • Local brand name: Masiviera
  • Indication: Treatment of non resectable locally advanced or metastatic pancreatic cancer
  • Pathway: orphan
  • Status: rejected

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EMA — authorised 18 December 2017

  • Application: EMEA/H/C/004159
  • Marketing authorisation holder: AB Science
  • Local brand name: Masipro
  • Indication: Treatment of mastocytosis
  • Pathway: orphan
  • Status: rejected

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EMA — authorised 20 April 2018

  • Application: EMEA/H/C/004398
  • Marketing authorisation holder: AB Science
  • Local brand name: Alsitek
  • Indication: Treatment of amyotrophic lateral sclerosis.
  • Pathway: orphan
  • Status: rejected

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EMA — authorised 19 December 2024

  • Application: EMEA/H/C/005897
  • Marketing authorisation holder: AB Science
  • Local brand name: Masitinib AB Science
  • Indication: In combination with riluzole for the treatment of adult patients with amyotrophic lateral sclerosis (ALS)
  • Pathway: orphan
  • Status: rejected

The European Medicines Agency (EMA) has approved Masitinib AB Science (AB1010) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) in combination with riluzole. This approval was granted under the orphan designation, which is reserved for medicines that treat rare diseases. The marketing authorisation holder is AB Science.

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Other Oncology approved in European Union

Frequently asked questions

Is AB1010 approved in European Union?

Yes. EMA authorised it on 22 November 2013; EMA authorised it on 23 January 2014; EMA authorised it on 18 December 2017.

Who is the marketing authorisation holder for AB1010 in European Union?

AB Science holds the EU marketing authorisation.