Klisyri
tirbanibulin
Table of contents
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.
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List item
Klisyri : EPAR - Medicine overview (PDF/118.09 KB)
First published: 21/07/2021
EMA/356530/2021 -
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List item
Klisyri : EPAR - Risk-management-plan summary (PDF/160.7 KB)
First published: 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 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 |
Almirall, S.A.
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
16/07/2021
|
Contact address |
Ronda General Mitre, 151 |
Product information
18/01/2022 Klisyri - EMEA/H/C/005183 - IB/0002
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
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.