Epiduo 0.1%/2.5% 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 18 October 2024
File name
ie-spc-epiduo-gel-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 6.1 - List of excipients
- 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
Excipient guidelines update
Updated on 18 October 2024
File name
(025026) P202045-2 EPIDUO 0.1 DS GEL 60 IRL INSERT (1).pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 11 May 2023
File name
(023887) P201232-3 EPIDUO GEL IENI LEAFLET.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Last updated in May 2023
Updated on 09 May 2023
File name
ie-spc-epiduo-0.1% gel-en-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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 November 2022
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
Section 10 was updated in line with the IE approval date in place of the RMS approval date.
Updated on 28 October 2022
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 April 2022
File name
Epiduo SPC PA22743-007-001.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
Date of renewal of the authorisation changed
Updated on 27 August 2021
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
This medicine contains 40 mg propylene glycol (E1520) in each gram which is equivalent to 4 %w/w, it may cause skin irritation.
This product contains propylene glycol (E1520) that may cause skin irritation.
4.8 Undesirable effects
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 directly via HPRA Pharmacovigilance, Website: www.hpra.ievia HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
10. DATE OF REVISION OF THE TEXT
August 2021
Updated on 14 July 2020
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 November 2018
File name
PLTASCP24569-6(4)+vCertification+1.0.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 November 2018
File name
Epiduo IRE SPC V4.pdf
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 15 June 2018
File name
Epiduo 45g PIL UK & IRE (P24569-9) eMC.pdf
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 06 June 2018
File name
Epiduo_IRE__SPC_.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 June 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 21 February 2018
File name
PIL_17316_268.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2018
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 02 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 February 2018
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 2: (E1520; 4.00%) has been added after 'excipient with known effect: propylene glycol'. This now reads: 'Excipient with known effect: Propylene glycol (E1520; 4.00%)
- Section 4.1: The following has been added: Epiduo is indicated in adults, adolescents and children aged 9 years and over.
- Section 4.5: Minor rewording. 'No interaction studies have been performed
conducted with Epiduo. - Section 4.8: Minor rewording of table headings and the addition of '(cannot be estimated from the available data)*' to the frequency column for Eye disorders; Respiratory, thoracic and mediastinal disorders; and skin and subcutaneous disorders.
- Section 5.1: Pharmacotherapeutic group changed. 'D10A' has been removed, and 'D10AD Retinoids for topical use in acne' has been added. Also a minor spelling change 'forth' to 'fourth'.
- Section 6.1: Change of 'glycerin' to 'glycerol'
- Section 10: Change of date to January 2018.
Updated on 29 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 September 2017
Reasons for updating
- New PIL for new product