Scemblix TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: asciminib
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet blister packDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Violet white, round, biconvex, film-coated tablets with beveled edges, approximately 8.2 mm diameter, unscored, debossed with 40 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 25 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 60 tablets pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 20 mg film-coated tablet blister packDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Pale yellow, round, biconvex, film-coated tablets with beveled edges, approximately 6.2 mm diameter, unscored, debossed with 20 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 25 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 60 tablets pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 20 mg film-coated tablet blister packDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Pale yellow, round, biconvex, film-coated tablets with beveled edges, approximately 6.2 mm diameter, unscored, debossed with 20 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 25 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 60 tablets pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on January, 1 2025. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet blister packDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Violet white, round, biconvex, film-coated tablets with beveled edges, approximately 8.2 mm diameter, unscored, debossed with 40 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 25 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 60 tablets pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on January, 1 2025. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 20 mg film-coated tablet bottleWhat this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Pale yellow, round, biconvex, film-coated tablets with beveled edges, approximately 6.2 mm diameter, unscored, debossed with 20 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 60 tablets pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on January, 1 2025. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet bottleWhat this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Violet white, round, biconvex, film-coated tablets with beveled edges, approximately 8.2 mm diameter, unscored, debossed with 40 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 300 tablets pack
- 60 tablets pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet bottleWhat this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Violet white, round, biconvex, film-coated tablets with beveled edges, approximately 8.2 mm diameter, unscored, debossed with 40 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 300 tablets pack
- 60 tablets pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on January, 1 2025. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 20 mg film-coated tablet bottleWhat this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Pale yellow, round, biconvex, film-coated tablets with beveled edges, approximately 6.2 mm diameter, unscored, debossed with 20 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 60 tablets pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
Brand name
(ARTG)
: SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet bottleWhat this medicine is used for
(ARTG)
SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). Ph+ CML in CP with the T315I mutation.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Violet white, round, biconvex, film-coated tablets with beveled edges, approximately 8.2 mm diameter, unscored, debossed with 40 on one side and Novartis logo on the other side
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Protect from Moisture
- Store in Original Container
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.
- 20 tablets pack
- 300 tablets pack
- 60 tablets pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient asciminib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
