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 13/08/2020

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
6
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

23/07/2020 Omidria - EMEA/H/C/003702 - R/0015

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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