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Salatac Gel

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Pharmacy Only: Non-prescription

Updated on 26 November 2024

File name

SALG-IPHA-PIL.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4 revised wording remove yellow card details add Via HPRA Pharmacovigilance website

Section 5 store remove on the fold and add at the end

Section 6 Marketing Authorisation delete UK details

Section 6 leaflet revised September 2024

Updated on 26 November 2024

File name

SALG-IPHA-SPC.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In Section 4.8 Undesirable effects 

 

The following text has been revised :

 

After Pharmacovigilance, IR address deleted and email removed

 

In Section 10 Date of revision of the text:

 

The date has changed to:

“November 2024”

Updated on 23 January 2023

File name

SALG-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through pharmacy only

Updated on 17 December 2020

File name

SALG-IPHA.SPC.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 17 December 2020

File name

EXTL-IPHA.SPC.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 31 August 2018

File name

SALG-IPHA.SPC.12.05.15.18.05.15.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 18 May 2015

File name

PIL_8670_54.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 May 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 18 May 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie.



In section 10 Date of revision of the text, the date has changed to "April 2015"

Updated on 18 May 2015

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 25 July 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 18 February 2010

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 9 (Renewal of the authorisation) - the date has changed to "21 November 2009"

In section 10 (Date of revision of the text) - the date has changed to "November 2009"

Updated on 30 November 2009

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 16 May 2005

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 20 January 2005

Reasons for updating

  • Improved electronic presentation

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only