KLISYRI Ointment Ref.[27964] Active ingredients: Tirbanibulin

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Almirall, S.A., Ronda General Mitre 151, 08022 Barcelona, Spain

Product name and form

Klisyri 10 mg/g ointment.

Pharmaceutical Form

Ointment.

White to off-white ointment.

Qualitative and quantitative composition

Each gram of ointment contains 10 mg of tirbanibulin.

Each sachet contains 2.5 mg of tirbanibulin in 250 mg ointment.

Excipients with known effects: Propylene glycol 890 mg/g ointment.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tirbanibulin

Tirbanibulin disrupts microtubules by direct binding to tubulin, which induces cell cycle arrest and apoptotic death of proliferating cells, and is associated with disruption of Src tyrosine kinase signalling.

List of Excipients

Propylene glycol
Glycerol monostearate 40-55

Pack sizes and marketing

Sachets with an inner layer of linear low-density polyethylene. Each sachet contains 250 mg of ointment.

Packs of 5 sachets.

Marketing authorization holder

Almirall, S.A., Ronda General Mitre 151, 08022 Barcelona, Spain

Marketing authorization dates and numbers

EU/1/21/1558/001

Date of first authorisation: 16 July 2021

Drugs

Drug Countries
KLISYRI Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United States

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