Scemblix 20 mg and 40 mg film-coated tablets
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 29 April 2026
File name
Scemblix REG PIL PF25-062 April 2026 TBI 24 Oct 2026 clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Updated following approval of a new indication “treatment of adult patients with CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib”, together with the additional 100 mg film-coated tablet strength.
Updated on 29 April 2026
File name
Scemblix REG SPC PF25-062 April 2026_clean IPHA.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC has been updated following approval of a new indication “treatment of adult patients with CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib”, together with the additional 100 mg film-coated tablet strength.
Updated on 24 November 2025
File name
Scemblix REG SPC PF25-210 November 2025_clean IPHA.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 Indication updated to ‘Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP)’.
Section 4.2 Updated to include dosing recommendations for patients switching from other treatments and additional information about missed doses and dose adjustment for adverse reactions
Section 4.4 Updated to include additional information in ‘Hepatitis B reactivation’.
Section 4.8 Reclassification of some AE’s and new AE’s added (constipation and hypothyroidism)
Sections 5.1, 5.2 and 5.3: Updated to include additional preclinical and clinical data from ASC4FIRST and ASC4OPT trials
Updated on 24 November 2025
File name
Scemblix-REG PIL_PF25-210 November 2025_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Updated due to approval of 1st line indication
Updated on 26 May 2025
File name
Scemblix_REG PIL_PF25-0113_25.04.2025_clean_Barcelona.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 May 2025
File name
Scemblix_REG SPC_PF25-0113_25.04.2025_clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 August 2024
File name
Scemblix_REG SPC_PF24-0156_July 2024_clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 August 2024
File name
Scemblix_REG SPC_PF24-0156_09Dec2024_clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 August 2024
File name
Scemblix_R89_REG PIL_PF24-0156_Clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 19 April 2024
File name
Scemblix_REG SPC_PF24-0082_Feb 2024_clean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 January 2024
File name
Scemblix_REG SPC_PF24-0018_Jan 2024_clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 January 2024
File name
Scemblix_R89_REG PIL_PF24-0018_Clean_14.12.2023.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 01 November 2023
File name
Scemblix_REG SPC_PF23-0131_July 2023_clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 November 2023
File name
Scemblix_REG PIL_Clean_24.07.2023_.pdf
Reasons for updating
- New PIL for new product
Novartis Ireland Limited
Address:
Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, IrelandMedical Information E-mail:
medinfo.dublin@novartis.comTelephone:
+353 1 2601255Fax:
+353 1 2601263