ITULAZAX 12 SQ-Bet oral lyophilisate

*
Pharmacy Only: Prescription
  • Company:

    ALK-Abello Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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)