Scemblix
asciminib
Table of contents
Overview
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.
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Scemblix : EPAR - Medicine Overview (PDF/123.39 KB)
First published: 07/09/2022
EMA/613753/2022 -
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Scemblix : EPAR - Risk management plan summary (PDF/85.65 KB)
First published: 07/09/2022
Authorisation details
Product details | |
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Name |
Scemblix
|
Agency product number |
EMEA/H/C/005605
|
Active substance |
asciminib hydrochloride
|
International non-proprietary name (INN) or common name |
asciminib
|
Therapeutic area (MeSH) |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
|
Anatomical therapeutic chemical (ATC) code |
L01EA06
|
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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
25/08/2022
|
Contact address |
Vista Building |
Product information
24/07/2023 Scemblix - EMEA/H/C/005605 - PSUSA/00011008/202210
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
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).