🇪🇺 Xolair in European Union

Xolair (omalizumab) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/005958
  • Local brand name: Omlyclo
  • Status: approved

Xolair 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 Xolair approved in European Union?

Yes. EMA has authorised it.

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

Roche is the originator. The local marketing authorisation holder may differ — check the official source linked above.