Klisyri

RSS

tirbanibulin

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

Overview

Klisyri is an ointment used to treat adults with mild actinic keratosis on the face and scalp. Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight.

Klisyri contains the active substance tirbanibulin. It is available as 250-mg sachets, each containing 2.5 mg of tirbanibulin.

This EPAR was last updated on 21/07/2021

Authorisation details

Product details
Name
Klisyri
Agency product number
EMEA/H/C/005183
Active substance
tirbanibulin
International non-proprietary name (INN) or common name
tirbanibulin
Therapeutic area (MeSH)
Keratosis, Actinic
Anatomical therapeutic chemical (ATC) code
D06BX03
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
Almirall, S.A.
Date of issue of marketing authorisation valid throughout the European Union
16/07/2021
Contact address

Ronda General Mitre, 151
ES-08022 Barcelona
Spain

Product information

16/07/2021 Klisyri - EMEA/H/C/005183 -

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antibiotics and chemotherapeutics for dermatological use

Therapeutic indication

Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

Assessment history

How useful was this page?

Add your rating