Rhokiinsa
netarsudil
Table of contents
Overview
Rhokiinsa is an eye-drop solution that is used to reduce pressure inside the eye in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Rhokiinsa contains the active substance netarsudil.
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List item
Rhokiinsa : EPAR - Medicine overview (PDF/128.33 KB)
First published: 03/12/2019
EMA/621772/2019 -
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Rhokiinsa : EPAR - Risk-management-plan summary (PDF/79.05 KB)
First published: 03/12/2019
Authorisation details
Product details | |
---|---|
Name |
Rhokiinsa
|
Agency product number |
EMEA/H/C/004583
|
Active substance |
Netarsudil
|
International non-proprietary name (INN) or common name |
netarsudil
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
S01EX05
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Santen Oy
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
19/11/2019
|
Contact address |
Niittyhaankatu 20 |
Product information
26/07/2022 Rhokiinsa - EMEA/H/C/004583 - N/0011
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
Reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.