🇪🇺 recombinant human C1 inhibitor in European Union

EMA authorised recombinant human C1 inhibitor on 31 December 2009

Marketing authorisation

EMA — authorised 31 December 2009

  • Application: EMEA/H/C/000769
  • Marketing authorisation holder: Pharming Group N.V.
  • Local brand name: Rhucin
  • Indication: Replacement treatment in acute attacks of angioedema in patients with congenital C1INH activity deficiency.
  • Status: rejected

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recombinant human C1 inhibitor in other countries

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

Other Immunology approved in European Union

Frequently asked questions

Is recombinant human C1 inhibitor approved in European Union?

Yes. EMA authorised it on 31 December 2009.

Who is the marketing authorisation holder for recombinant human C1 inhibitor in European Union?

Pharming Group N.V. holds the EU marketing authorisation.