Omidria
phenylephrine / ketorolac
Table of contents
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.
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List item
Omidria : EPAR - Summary for the public (PDF/78.11 KB)
First published: 01/09/2015
Last updated: 01/09/2015
EMA/359266/2015 -
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List item
Omidria : EPAR - Risk-management-plan summary (PDF/101.16 KB)
First published: 01/09/2015
Last updated: 13/08/2020
Authorisation details
Product details | |
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Name |
Omidria
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Agency product number |
EMEA/H/C/003702
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Active substance |
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International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
S01
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Publication details | |
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Marketing-authorisation holder |
Rayner Surgical (Ireland) Limited
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Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
28/07/2015
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Contact address |
First Floor |
Product information
06/03/2023 Omidria - EMEA/H/C/003702 - T/0022
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.