Salatac Gel
*Company:
Dermal Laboratories (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
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 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