🇪🇺 CycloSPORINE Ophthalmic in European Union

EMA authorised CycloSPORINE Ophthalmic on 19 March 2015

Marketing authorisation

EMA — authorised 19 March 2015

  • Application: EMEA/H/C/002066
  • Marketing authorisation holder: Santen Oy
  • Local brand name: Ikervis
  • Indication: Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
  • Status: approved

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Other Ophthalmology approved in European Union

Frequently asked questions

Is CycloSPORINE Ophthalmic approved in European Union?

Yes. EMA authorised it on 19 March 2015.

Who is the marketing authorisation holder for CycloSPORINE Ophthalmic in European Union?

Santen Oy holds the EU marketing authorisation.