ITULAZAX 12 SQ-Bet oral lyophilisate
*Company:
ALK-Abello LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 May 2025
File name
SmPC-IE-TRE-12May2025.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Removal of black triangle and addition/updates relating to 5 years+ indication
Updated on 19 May 2025
File name
PL-IE-TRE-19Apr2025.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Changes to remove black triangle and add indication and associated information for 5 years+
Updated on 10 February 2025
File name
SmPC-IE-TRE-09Jan2025.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to add the allergen content
Updated on 10 February 2025
File name
PL-IE-TRE-09Jan2025.pdf
Reasons for updating
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Change to add allergen content
Updated on 10 February 2025
File name
PL-IE-TRE-09Jan2025.pdf
Reasons for updating
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Change to add allergen content
Updated on 15 March 2024
File name
SPC_IE_PA1255-007-001-Itulazax_2Nov2023.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Correction to date in Section 9
Updated on 09 February 2024
File name
SmPC-IE-TRE-30Nov2023-clean-renewal.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
Renewal
Updated on 19 October 2023
File name
SmPC-IE-TRE-09Oct2023-var014-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 June 2023
File name
itulazax-SPC-01122022-cl.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 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to all relevant sections to update 'oral lyophilisate' to 'sublingual lyophilisate
Updated on 21 June 2023
File name
itulazax-mockup-PIL-01122022.pdf
Reasons for updating
- Change to Section 1 - what the product is
Free text change information supplied by the pharmaceutical company
Updated form from 'oral lyophilisate' to 'sublingual lyophilisate'
Updated on 28 March 2022
File name
SPC_IE_PA1255-007-001-Itulazax_Feb2022.pdf
Reasons for updating
- 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 be renewed (B)
Updated on 11 February 2021
File name
SPC_IE_PA1255-007-001-Itulazax_Jan2021.pdf
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
Update to reflect shelf life increase
Updated on 16 June 2020
File name
SPC_IE_PA1255-007-001-Itulazax_June2020.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 June 2020
File name
PIL_IE_Itulazax_Jun2019.pdf
Reasons for updating
- New PIL for new product
Updated on 15 June 2020
File name
SPC_IE_PA1255-007-001-Itulazax_June2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
ALK-Abello Ltd
Address:
1 Manor Park, Manor Farm Road, Reading, Berkshire, RG2 0NA, UKMedical Information E-mail:
infouk@alk.netTelephone:
+44 (0)118 903 7940Medical Information Direct Line:
+44 (0)118 903 7940Customer Care direct line:
+44 (0)118 903 7940