Differin Gel
*Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
No Recent UpdateLegal 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 09 April 2024
File name
ie-mockup-leaflet.pdf
Reasons for updating
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Ecipient 'Carbomer 940' updated to 'Carbomer'
Updated on 09 April 2024
File name
ie-spc-clean.pdf
Reasons for updating
- 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
SPC uploaded on 08-04-2024 was missing revision date
Updated on 08 April 2024
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Exciepient name updated from 'Carbomer 940' to 'Carbomer'
Updated on 11 November 2022
File name
(020821) P27722-4 DIFFERIN GEL 30 IRL LEAFLET (1).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 November 2022
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 February 2022
File name
(020821) P27722-3 DIFFERIN GEL 30 IRL LEAFLET.pdf
Reasons for updating
- XPIL Updated
Updated on 20 September 2021
File name
ie-spc-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 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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Adapalene 0.1% w/w
Excipients with known effect:
One gram of gel contains 40mg of Propylene glycol (E1520)
4.4 Special warnings and precautions for use
This medicine contains 40mg propylene glycol (E1520) in each gram which is equivalent to 4% w/w. It may cause skin irritation. This medicine also contains The excipient propylene glycol (E1520) may cause skin irritation and
10. DATE OF REVISION OF THE TEXT
March 202130th September 2019
Updated on 20 September 2021
File name
(020821) P27722-3 DIFFERIN GEL 30 IRL LEAFLET.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Differin contains:
- 40mg of propylene glycol (E1520) in each gram which is equivalent to 4% w/w, it may cause skin irritation
propylene glycol (El 520) which may cause skin irritation
This leaflet was last revised in 0379
Updated on 20 September 2021
File name
ie-spc-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 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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect:
One gram of gel contains 40mg of Propylene glycol (E1520)
4.4 Special warnings and precautions for use
This medicine contains 40mg propylene glycol (E1520) in each gram which is equivalent to 4% w/w. It may cause skin irritation. This medicine also contains The excipient propylene glycol (E1520) may cause skin irritation and
10. DATE OF REVISION OF THE TEXT
March 202130th September 2019
Updated on 12 June 2020
File name
Differin gel 30g PIL IRE V11 (P27722-2).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Free text change information supplied by the pharmaceutical company
Change to MAH and MA number.
Updated on 09 February 2020
File name
ie-spc-current-DifferinGel-Sep19.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 October 2018
File name
Differin gel 30g PIL IRE V10 (P27722-1) emc.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 24 October 2018
File name
Differin Gel IRE SPC V21.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 December 2017
Reasons for updating
- 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 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
Section 4.8 - Reorganised ADRs according to SOC
Section 10 - Update revision of text date
Updated on 04 December 2017
File name
PIL_7862_577.pdf
Reasons for updating
- New PIL for new product
Updated on 04 December 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 November 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 23 October 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 13 August 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 22 September 2009
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 June 2009
Reasons for updating
- Improved electronic presentation
Updated on 09 April 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 06 August 2008
Reasons for updating
- 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
Change to the date of revision of the text
Updated on 27 May 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 March 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 March 2007
Reasons for updating
- Change to date of revision
Updated on 28 September 2005
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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:Product subject to medical prescription which may be renewed (B)
Updated on 23 May 2005
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 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 28 May 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)