Roclanda

RSS

latanoprost / netarsudil

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

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.  

This EPAR was last updated on 13/12/2022

Authorisation details

Product details
Name
Roclanda
Agency product number
EMEA/H/C/005107
Active substance
  • Latanoprost
  • Netarsudil mesilate
International non-proprietary name (INN) or common name
latanoprost / netarsudil
Therapeutic area (MeSH)
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Anatomical therapeutic chemical (ATC) code
S01EE
Additional monitoringAdditional 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
33720 Tampere
Finland

Product information

12/12/2022 Roclanda - EMEA/H/C/005107 - N/0012

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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

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.

Assessment history

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