Acnecide Gel 5%
*Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
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 27 October 2023
File name
SmPC Acnecide IE Oct 2023.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
Addition of 40g pack size to product licence.
Updated on 27 October 2023
File name
ie-mockup-pl-clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of 40g pack size to product licence.
Updated on 27 October 2023
File name
ie-mockup-pl-clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of 40g pack size to product licence.
Updated on 31 August 2022
File name
ie-mockup-pl-July2022-v3-P200908-1-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to date of revision
Updated on 31 August 2022
File name
ie-spc-29August2022-v2-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 15 August 2022
File name
ie-mockup-pl-March2022-v2-P200908-0-clean.pdf
Reasons for updating
- XPIL Updated
Updated on 19 May 2022
File name
ie-mockup-pl-March2022-v2-P200908-0-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 19 May 2022
File name
ie-spc-19May2022-v1-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 03 March 2022
File name
ie-mockup-pl-Jan2022-v1-P200908-0-clean.pdf
Reasons for updating
- Correction of spelling/typing errors
- Change to date of revision
Updated on 20 January 2022
File name
ie-mockup-pil-April2019.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 09 February 2020
File name
ie-spc-current-Acnecide-May19.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- File format updated to PDF
Legal category:Supply through pharmacy only
Updated on 21 September 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 21 September 2017
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.3 - Preclinical safety data
- 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
Section 4.2 - Update to method of administration
Section 4.3 - QRD change
Section 4.4 - Addition of warning regarding swelling/blistering of the skin
Section 4.6 - Restructuring/Rewording of the section
Section 4.8 - Addition of ADRs regarding allergic reactions
Section 4.9 - Restructuring/rewording of the section
Section 5.3 - Restructuring/Rewording of the section
Section 10 - Updated revision date
Section 4.3 - QRD change
Section 4.4 - Addition of warning regarding swelling/blistering of the skin
Section 4.6 - Restructuring/Rewording of the section
Section 4.8 - Addition of ADRs regarding allergic reactions
Section 4.9 - Restructuring/rewording of the section
Section 5.3 - Restructuring/Rewording of the section
Section 10 - Updated revision date
Updated on 20 September 2017
File name
PIL_9664_947.pdf
Reasons for updating
- New PIL for new product
Updated on 20 September 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 08 April 2015
Reasons for updating
- Product/presentation re-marketed
Updated on 10 October 2013
Reasons for updating
- Change to further information section
Updated on 09 September 2013
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 3 (pharmaceutical form), off-white has been added to the apprearance of the gel.
Updated on 13 June 2011
Reasons for updating
- Introduction of new pack/pack size
Updated on 03 June 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Addition of 30g pack size.
Updated on 01 April 2011
Reasons for updating
- Change to side-effects
Updated on 04 March 2011
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
The shelf life of the product has been reduced from 36 months to 24 months.
Updated on 02 February 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
The adverse events listed in section 4.8 have been presented in a table accroding to system organ class and frequency of occurence. Some additional adverse events have also been added to the table in section 4.8.
Updated on 09 July 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 25 February 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Update to section 4.4 - Special Warnings and Special Precautions for Use
Updated on 19 March 2007
Reasons for updating
- Addition of marketing authorisation holder
Updated on 30 August 2006
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Section 7 Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8 JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS
Updated on 16 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only