Etrivex 500 micrograms/g Shampoo
*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 23 February 2024
File name
20240222 Etrivex Ireland PIL - Case Reference Number CRN00DZDC - clean - from HPRA web-site.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL revision in-line with MRP approved Art.61(3) procedure SE/H/1985/01/P/02 submitted 15Nov2023; approved: 25Jan2024 by RMS authority and 31Jan2024 by HPRA (ref. CRN00DZDC) to reflect 'Clobetasol propionate is classed as a very potent corticosteroid' PIL wording (n.b. submission instigated by MHRA).
Updated on 14 November 2022
File name
ie-spc-3November2022-v2-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)
Updated on 26 October 2022
File name
ie-spc-24October2022-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 26 October 2022
File name
ie-mockup-pl-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 August 2022
File name
ie-pil-mockup-May2021-P23932-6-V1-Clean.pdf
Reasons for updating
- XPIL Updated
Updated on 24 February 2022
File name
ie-pil-mockup-May2021-P23932-6-V1-Clean.pdf
Reasons for updating
- XPIL Updated
Updated on 27 May 2021
File name
ie-mockup-pl-clean-26May2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 27 May 2021
File name
ie-spc-clean-26May2021.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 May 2021
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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)
Updated on 18 June 2020
File name
Etrivex shampoo PIL UK & IRE V6 (P23932-5)emc.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of blurred vision as a warning and AE
Updated on 09 February 2020
File name
ie-spc-current-Etrivex-Dec19.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 11 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 October 2017
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
Updated on 29 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- 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 4.2 - Addition of weekly dosage limit and QRD changes
Section 4.3 - Additional contraindication regarding contact with eyelids (risk of glaucoma)
Section 4.4 - Revised section, with inclusion of warning regarding diabetes, signs of intolerance and use in children between 2 - 18 years of age
Section 4.6 - QRD change (Fertility)
Section 4.7 - Revised sentence structure
Section 4.8 - Revised ADR table
Section 5.1 - QRD change
Section 5.2 - Revised sentence structure
Section 6.4 - Amended storage conditions
Section 10 - Updated date of text revision
Updated on 15 September 2017
File name
PIL_12411_820.pdf
Reasons for updating
- New PIL for new product
Updated on 15 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 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 14 July 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 - Date of text revision amended
Updated on 13 July 2017
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 04 July 2013
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
Updated on 24 June 2009
Reasons for updating
- Improved electronic presentation
Updated on 06 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 28 August 2007
Reasons for updating
- New PIL for new product
Updated on 15 August 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)