🇪🇺 Nitisinone in Arm A in European Union

EMA authorised Nitisinone in Arm A on 21 February 2005

Marketing authorisation

EMA — authorised 21 February 2005

  • Application: EMEA/H/C/000555
  • Marketing authorisation holder: Swedish Orphan Biovitrum International AB
  • Local brand name: Orfadin
  • Indication: Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine. Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).
  • Status: approved

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Nitisinone in Arm A 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 Nitisinone in Arm A approved in European Union?

Yes. EMA authorised it on 21 February 2005.

Who is the marketing authorisation holder for Nitisinone in Arm A in European Union?

Swedish Orphan Biovitrum International AB holds the EU marketing authorisation.