Zolgensma Combination Pack 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: onasemnogene abeparvovec
Brand name
(ARTG)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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)
: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 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)
ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless,to faint white solution.
Component :
- Injection, intravenous infusion
- Intravenous
- When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.
Storage conditions
(ARTG)
- Store between minus 60 - minus 80 degrees
- Store in Original Container
- Shelf lifetime is 12 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.
- 1 vial of 5.5 mL and 2 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 3 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 4 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 5 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 6 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 7 vials of 8.3 mL pack
- 1 vial of 5.5 mL and 8 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 1 vial of 8.3 mL pack
- 2 vials of 5.5 mL and 2 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 3 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 4 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 5 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 6 vials of 8.3 mL pack
- 2 vials of 5.5 mL and 7 vials of 8.3 mL pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient onasemnogene abeparvovec
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.
For the active ingredient onasemnogene abeparvovec
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
