Xolair 150 mg solution for injection in pre-filled syringe
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 January 2024
File name
Xolair 150 mg 26 gauge PFS_REG PIL_PF24_0008_Dec2023_clean_IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 25 January 2024
File name
Xolair 150 mg 26 gauge PFS_REG PIL_PF24_0008_Dec2023_clean_IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 17 November 2023
File name
Xolair 150mg and 300mg sol for injection_REG SPC_PF22-0164_06.11.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 November 2023
File name
Xolair 150mg and 300mg sol for injection_REG SPC_PF22-0164_06.11.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 November 2023
File name
Xolair 150 mg 26 gauge PFS_REG PIL_PF22-0164_06.11.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 7 - Instructions for use
Updated on 17 November 2023
File name
Xolair 150 mg 26 gauge PFS_REG PIL_PF22-0164_06.11.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 7 - Instructions for use
Updated on 23 March 2023
File name
Xolair Soln for Injection PFS 150mg_REG SPC_PF23-0056_clean_IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 February 2023
File name
Xolair 150mg PFS_REG PIL_PF23-0029_31.01.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 15 December 2021
File name
Xolair Soln for Injection PFS 150mg_REG SPC_PF 21-0322_clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 November 2021
File name
Xolair Soln for Injection PFS 150mg_REG SPC_PF 21-0289_Clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 November 2021
File name
Xolair 150 mg PFS_REG PIL_PF21-0289_25.10.2021_clean.pdf
Reasons for updating
- Change to storage instructions
Updated on 20 October 2021
File name
Xolair 150 mg PFS_REG PIL_PF21-0215_11.10.2021_clean_TBI08Jul2022.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 10 August 2020
File name
Xolair Soln for Inj 150mg REG PIL_PF19-0239_July 2020_Clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 August 2020
File name
Xolair Soln for Injection 150mg_REG SPC_PF 19-0293_Clean_IPHA.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2019
File name
Xolair Soln for Inj 150mg REG PIL_PF19-0143_July 2019_Clean.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 29 July 2019
File name
Xolair Soln for Inj 150mg REG PIL_PF19-0143_July 2019_Clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 29 July 2019
File name
Xolair Soln for Inj 150mg REG SPC_PF19-0143_July 2019_IPHA.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes have been made to section 4.6 Fertility, Pregnancy and Lactation. These changes affect Pregnancy and Breast-feeding sections only.
Updated on 12 March 2019
File name
Xolair 150mg Solution REG PIL 10005678_06_R91_IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 28 January 2019
File name
Xolair 150mg Solution REG PIL 10005678_05_R91_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 28 January 2019
File name
Xolair 150mg Solution for Injection REG SPC_PF 19-0005_clean_IPHA.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 January 2019
File name
Xolair 150mg Solution for Injection REG SPC_PF 19-0005_clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 January 2019
File name
Xolair 75mg Solution for Injection REG SPC_PF 19-0005_clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 December 2018
File name
Xolair 150mg Solution for Injection REG SPC_PF 18-0265_clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2018
File name
Xolair_150mg_solutionforinjection_REG_SmPC_PF18-0063_clean.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2016
File name
PIL_15995_818.pdf
Reasons for updating
- New PIL for new product
Updated on 16 November 2016
Reasons for updating
- Change to section 4 - possible side effects
Updated on 23 September 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 September 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Systemic lupus erythematosus
Clinical trial and post-marketing cases of systemic lupus erythematosus (SLE) have been reported in patients with moderate to severe asthma and CSU. The pathogenesis of SLE is not well understood.
Updated on 04 May 2016
Reasons for updating
- Change to side-effects
- Change to appearance of the medicine
Updated on 05 April 2016
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 3 - Updated "Clear to opalescent, slightly yellow to brown solution." to "Clear to slightly opalescent, colourless to pale brownish-yellow solution."
Section 4.4 - Replaced "Anaphylactic reactions were rare in clinical trials (see section 4.8)." with "A history of anaphylaxis unrelated to omalizumab may be a risk factor for anaphylaxis following Xolair administration."
Section 4.8 - Added "Anaphylaxis
Anaphylactic reactions were rare in clinical trials. However, post-marketing data following a cumulative search in the safety database retrieved a total of 898 anaphylaxis cases. Based on an estimated exposure of 566,923 patient treatment years, this results in a reporting rate of approximately 0.20%."
Updated on 23 October 2015
Reasons for updating
- Change to improve clarity and readability
Updated on 12 July 2015
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5 - added "Since IgE may be involved in the immunological response to some helminth infections," before "Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4)."
Section 4.6 - specified that the specifically-designed non-clinical fertility studies were in non-human primates.
Section 4.8 - deleted
Section 5.1 - added some clarification text.
Section 5.3 - added some clarification text.
Section 6.6 - added "Any unused medicinal product or waste material should be disposed of in accordance with local requirements."
Section 6.5 - added "Pack containing 1 pre-filled syringe, and multipacks containing 4 (4 packs of 1) or 10 (10 packs of 1) pre-filled syringes. and deleted
Updated on 04 February 2015
Reasons for updating
- Change to marketing authorisation holder
Updated on 09 December 2014
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 - update to MAH details
Updated on 01 October 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 28 August 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 added:
"Latex-sensitive individuals
The removable needle cap of this pre‑filled syringe contains a derivative of natural rubber latex. No natural rubber latex has to date been detected in the removable needle cap. Nevertheless, the use of Xolair solution for injection in pre-filled syringe in latex-sensitive individuals has not been studied and thus there is a potential risk for hypersensitivity reactions which cannot be completely ruled out."
Section 4.8:
Corrected the Irish HA's contact details to reflect recent name change from IMB to HPRA.
Updated on 24 April 2014
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 11 March 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - added new text on reporting side effects.
Updated on 05 December 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Deleted paragraph on Malignancies.
Section 4.6
Re-worded the details on Pregnancy and breast-feeding
Section 4.8
Deleted paragraph on Malignancies and updated paragrapgh on ATE's.
Updated on 08 June 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 April 2012
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The shelf life includes potential temperature excursions. The product may be kept for a total of 4 hours at 25°C. If necessary, the product may be returned to the refrigerator for later use, but this must not be done more than once.
Section 6.6 added instructions for priimg the syringe.
Updated on 27 June 2011
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - added in "anti-therapeutic antibody development" as a rare adverse event.
Section 5.2 - update the Absortion section with "Administration of Xolair manufactured as a lyophilised or liquid formulation resulted in similar serum concentration-time profiles of omalizumab."
Updated on 07 January 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)