GRAZAX 75,000 SQ-T oral lyophilisate
- Name:
GRAZAX 75,000 SQ-T oral lyophilisate
- Company:
ALK-Abello Ltd
- Active Ingredients:
allergen extract of grass pollen from Timothy (Phleum pratense)
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/07/20
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ALK-Abello Ltd
Company Products
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 3 July 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 3 July 2020 SPC
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 4.5 - 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 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 July 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 27 November 2018 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 November 2017 SPC
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
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 SPC
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
Updated on 16 October 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 6 February 2014 SPC
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 on 17 January 2014 SPC
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 on 14 January 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 5 December 2012 SPC
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
Updated on 30 November 2012 PIL
Reasons for updating
- Change to side-effects
Updated on 4 January 2012 SPC
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
Updated on 15 December 2011 PIL
Reasons for updating
- Change to how the medicine works
Updated on 16 June 2011 PIL
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 16 June 2011 SPC
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 4.6 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 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 SPC
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
Updated on 21 January 2010 SPC
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 4.2 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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)