GRAZAX 75,000 SQ-T oral lyophilisate

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Summary of Product Characteristics last updated on medicines.ie: 27/11/2018

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ALK-Abello Ltd

ALK-Abello Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name GRAZAX 75,000 SQ-T oral lyophilisate Active Ingredients allergen extract of grass pollen from Timothy (Phleum pratense)
Medicine Name Jext 150mcg Active Ingredients Adrenaline tartrate
Medicine Name Jext 300mcg Active Ingredients Adrenaline tartrate
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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 10 July 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 27 November 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.3 updated due to change in shelf life from 4 years to 5 years from manufacture

Updated on 29 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 29 November 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update throughout to include data from GT21 trial

Updated on 24 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 November 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 4 - possible side effects

Updated on 18 July 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 October 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of eosinophilic esophagitis to Rare

Updated on 16 October 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 6 February 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated 4.8 to include IMB address

Updated on 17 January 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Added section on how to report a side effect

Updated on 14 January 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 5 December 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Adjusted frequency of side effects in line with new MeDRA categories

Updated on 30 November 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 4 January 2012 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 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.4 and 5.1 have been updated to include 2 years of follow up data from ongoing clinical trials

Updated on 15 December 2011 PIL

Reasons for updating

  • Change to how the medicine works

Updated on 16 June 2011 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.5 - Nature and contents of container
  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 updated to include QRD headings, Posology, Paediatric population and Method of administration
Section 4.6 updated to include heading 'Fertility, pregnancy and lactation'  and section on 'Fertility' included
Section 6.5 updated to include number of blisters per pack

Updated on 16 June 2011 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 10 January 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 November 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 5 November 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated inline with MeDRA convention frequencies for system organ class Adverse Drug Reactions.

Updated on 21 January 2010 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 4.1  -  Disease Modifying Treatment has been included.


In Section 4.2 the following text has been added...

It is recommended to continue treatment with Grazax for a period of 3 years. Data is available for 3 years of treatment and 1 year of follow-up in adults. No data on treatment with Grazax in children beyond one grass pollen season is available.

In Section 4.8 immune system reactions have been added.

In Section 5.1 the following text has been added.

Mode of action

Specific immunotherapy with allergen products is the repeated administration of allergens to allergic individuals in order to activate immunomodulatory mechanisms and provide sustained relief of symptoms and less need for medications, and improvement in quality of life during subsequent natural allergen exposure.

Continuous daily treatment with Grazax in adult patients for 3 years resulted in disease modification as demonstrated by a sustained effect after the completion of treatment (effect demonstrated at one year follow-up).

Grazax is used for disease-modifying treatment of patients with grass pollen induced rhinitis and rhinoconjunctivitis..

 

The immune system is the target for the pharmacodynamic effect. The aim is to induce an immune response against the allergen with which the patient is treated. The complete and exact mechanism of action regarding clinical effect of specific immunotherapy is not fully understood and documented. Treatment with Grazax has shown to induce a systemic competitive antibody response towards grass, and it induces an increase in specific IgG continuously over 3 years of treatment. The clinical significance of these findings has not been established.

Updated on 14 January 2010 PIL

Reasons for updating

  • Change to how the medicine works
  • Change to date of revision

Updated on 26 June 2009 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 June 2009 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided