Omidria

RSS

phenylephrine / ketorolac

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Omidria. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Omidria.

For practical information about using Omidria, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 29/04/2019

Authorisation details

Product details
Name
Omidria
Agency product number
EMEA/H/C/003702
Active substance
  • ketorolac
  • phenylephrine
International non-proprietary name (INN) or common name
phenylephrine / ketorolac
Therapeutic area (MeSH)
  • Lens Implantation, Intraocular
  • Pain, Postoperative
Anatomical therapeutic chemical (ATC) code
S01
Publication details
Marketing-authorisation holder
Omeros Ireland Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
28/07/2015
Contact address

Omeros Ireland Limited
Ormond Building
31-36 Ormond Quay Upper
Dublin 7
Ireland

Product information

25/03/2019 Omidria - EMEA/H/C/003702 - T/0010

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic 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.

Assessment history

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