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Xolair TM
Listen to the Pronunciation:
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: inert substance, omalizumab
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 75mg powder for injection vial with diluent ampouleConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, powder for
- Subcutaneous
- White to off white cake.
Component :
- Injection, solution
- Subcutaneous
- Clear, colourless solution.
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Reconstituted Solution see label for shelf life
- Shelf lifetime is 3 Years.
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 active vial & 1 diluent ampoule pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 150mg powder for injection vial with diluent ampouleConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Injection, powder for
- Subcutaneous
- White to off white cake.
Component :
- Injection, solution
- Subcutaneous
- Clear, colourless solution.
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Reconstituted Solution see label for shelf life
- Shelf lifetime is 4 Years.
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 active vial & 1 diluent ampoule pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 75 mg solution for injection pre-filled syringeConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 1 syringe pack
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on July, 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 omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled syringeConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 1 syringe pack
- Pack containing 4 syringes pack
- Pack containing 10 syringes pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on July, 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 omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 300 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 1 syringe pack
- Pack containing 4 syringes pack
- Pack containing 10 syringes pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 300 mg solution for injection pre-filled syringeConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 75 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 300 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 1 syringe pack
- Pack containing 4 syringes pack
- Pack containing 10 syringes pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 300 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 1 syringe pack
- Pack containing 4 syringes pack
- Pack containing 10 syringes pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 75 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 300 mg solution for injection pre-filled syringeConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 300 mg solution for injection pre-filled syringeConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 150 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Brand name
(ARTG)
: XOLAIR omalizumab (rch) 75 mg solution for injection pre-filled penConsumer Medicine Information (CMI)
Read the CMI leaflet for facts you need to know before, during and after taking your medicine.
Listen to the audio transcription of the CMI leaflet.
For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).
What this medicine is used for
(ARTG)
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, solution
- Subcutaneous
- Clear to opalescent, slightly yellow to brownish-yellow solution for injection
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 18 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.
- Pack containing 10 syringes pack
- Pack containing 4 syringes pack
- Pack containing 1 syringe pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient omalizumab
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
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
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