🇪🇺 Replagal in European Union

EMA authorised Replagal on 3 August 2001

Marketing authorisation

EMA — authorised 3 August 2001

  • Application: EMEA/H/C/000369
  • Marketing authorisation holder: Takeda Pharmaceuticals International AG Ireland Branch
  • Local brand name: Replagal
  • Indication: Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
  • Status: approved

Read official source →

Replagal in other countries

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

Other Rare Disease approved in European Union

Frequently asked questions

Is Replagal approved in European Union?

Yes. EMA authorised it on 3 August 2001.

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

Takeda Pharmaceuticals International AG Ireland Branch holds the EU marketing authorisation.