Etrivex 500 micrograms/g Shampoo

Product Information *

  • Company:

    Galderma International S.A.S. c/o Galderma (U.K) Ltd.
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 27 May 2021

File name

ie-mockup-pl-clean-26May2021_1622126699.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_1622126354.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_1622126200.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_1592478418.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_1581288974.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

  • 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 revision of text

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 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 6.3 - Shelf-life after first opening amended
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

The date of revision of the text has been updated as the result of the MA being renewed.

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)