Xolair 150mg solution for injection

  • Name:

    Xolair 150mg solution for injection

  • Company:
    info
  • Active Ingredients:

    Omalizumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/19

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Summary of Product Characteristics last updated on medicines.ie: 29/7/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 114 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 9 August 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 July 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 29 July 2019 SmPC

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 PIL

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 28 January 2019 SmPC

Reasons for updating

  • Other

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 January 2019 SmPC

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 SmPC

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 SmPC

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 SmPC

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 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 November 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 23 September 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 September 2016 SmPC

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

Section 4.8 - added SLE as a rare side effect in the table and added the following text:

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 4 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to appearance of the medicine

Updated on 5 April 2016 SmPC

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 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 12 July 2015 SmPC

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 1 - deleted "omalizumab"
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 Over 4,400 allergic asthma patients were randomised in controlled efficacy trials with Xolair.
and added some clarifications.
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 Pack sizes of 1, 4 or 10.

Updated on 4 February 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 9 December 2014 SmPC

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 6.3 - Shelf life increased from 12 to 15 months
Section 7 - update to MAH details

Updated on 1 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 28 August 2014 SmPC

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 PIL

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 11 March 2014 SmPC

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 4.1, 4.2, 4.5, 4.8, 5.1 and 5.2 all updated as a result of the new indication for Chronic Spontaneous Urticaria.
Section 4.8 - added new text on reporting side effects.

Updated on 5 December 2013 SmPC

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

Section 4.4:
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 8 June 2012 SmPC

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

In section 4.2 the dosing tables have been updated to reduce the dosing frequency in certain situations from every two weeks to every four weeks and doubling the dose.

Updated on 12 April 2012 SmPC

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

Section 6.3 Added
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 SmPC

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 4.6 - update the wording of the fertility section.
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."
Section 5.3 updated the pre-clinial safety data.

Updated on 7 January 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided