This medicine is authorised for use in the European Union.


Scemblix is a cancer medicine. It is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in the ‘chronic’ phase (this is when the condition is developing slowly and the patient has few or no symptoms). The medicine can be used in adult patients whose cancer is ‘Philadelphia‑chromosome positive’ (Ph+). Ph+ means that two of the patient’s chromosomes have rearranged themselves and formed a special chromosome called the Philadelphia chromosome. This chromosome produces an enzyme, BCR::ABL1 kinase, that leads to the development of leukaemia.

Scemblix is used in patients who have already been treated with two or more cancer medicines called tyrosine kinase inhibitors.

CML is rare, and Scemblix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 March 2020.

This EPAR was last updated on 22/09/2023

Authorisation details

Product details
Agency product number
Active substance
asciminib hydrochloride
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Anatomical therapeutic chemical (ATC) code
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.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4

Product information

24/07/2023 Scemblix - EMEA/H/C/005605 - PSUSA/00011008/202210

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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

Antineoplastic agents

Therapeutic indication

Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).

Assessment history

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