🇪🇺 Phenylephrine-ketorolac in European Union

EMA authorised Phenylephrine-ketorolac on 28 July 2015

Marketing authorisation

EMA — authorised 28 July 2015

  • Application: EMEA/H/C/003702
  • Marketing authorisation holder: Rayner Surgical (Ireland) Limited
  • Local brand name: Omidria
  • Indication: Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
  • Status: approved

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Phenylephrine-ketorolac 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 Phenylephrine-ketorolac approved in European Union?

Yes. EMA authorised it on 28 July 2015.

Who is the marketing authorisation holder for Phenylephrine-ketorolac in European Union?

Rayner Surgical (Ireland) Limited holds the EU marketing authorisation.