Scemblix - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

asciminib

Opinion

On 16 October 2025 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Scemblix. The marketing authorisation holder for this medicinal product is Novartis Europharm Limited.

The CHMP adopted a change to the existing indication as follows:

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).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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CHMP post-authorisation summary of positive opinion for Scemblix (II-EMAVR0000265010)

Adopted Reference Number: EMADOC-1700519818-2475296

Key facts

• Name of medicine:
  Scemblix
• EMA 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 therapeutical 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.

• Marketing authorisation holder:
  Novartis Europharm Limited
• Date of opinion:
  16/10/2025
• Status:
  Positive