Roclanda
latanoprost / netarsudil
Table of contents
Overview
Roclanda is an eye-drop solution for reducing 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). It is for patients in whom treatment with either a prostaglandin medicine or netarsudil alone did not sufficiently reduce the pressure.
Roclanda contains the active substances latanoprost and netarsudil.
-
List item
Roclanda : EPAR - Medicine overview (PDF/138.47 KB)
First published: 21/01/2021
EMA/686057/2020 -
-
List item
Roclanda : EPAR - Risk-management-plan summary (PDF/283.73 KB)
First published: 21/01/2021
Authorisation details
Product details | |
---|---|
Name |
Roclanda
|
Agency product number |
EMEA/H/C/005107
|
Active substance |
|
International non-proprietary name (INN) or common name |
latanoprost / netarsudil
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
S01EE
|
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 | |
---|---|
Marketing-authorisation holder |
Santen Oy
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
07/01/2021
|
Contact address |
Niittyhaankatu 20 |
Product information
12/12/2022 Roclanda - EMEA/H/C/005107 - N/0012
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
Roclanda is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.