🇪🇺 Xibrom in European Union

Xibrom (BROMFENAC) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/001198
  • Local brand name: Yellox
  • Status: approved

Xibrom in other countries

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

Other Ophthalmology approved in European Union

Frequently asked questions

Is Xibrom approved in European Union?

Yes. EMA has authorised it.

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

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