Eumovate Ointment

Product Information *

  • Company:

    GlaxoSmithKline (Ireland) 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 10 March 2021

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

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

Updated on 10 March 2021

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 12 February 2021

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 26 November 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 13 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 13 December 2017

Reasons for updating

  • New PIL for new product

Updated on 13 December 2017

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)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Warnings and Precautions - added statement for visual disturbances
Section 4.8 - Undesirable effects  - added blurred vision

Updated on 13 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 12 October 2016

Reasons for updating

  • Change to improve clarity and readability

Updated on 01 September 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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

• Sections 4.2 and 4.4 of SmPC: updated to include the recommended paediatric population statements.
• Section 4.1 of the SmPC: updated as a result of the additional information recommended by the Article 45.
• Section 4.3 of the SmPC: Minor editorial changes

Updated on 31 August 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 12 August 2016

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 2 – update to the expression of active ingredient from w/w% to mg

Sections 4.1, indications – updated with addition of indications to bring in line with GDS, addition of information requested by the HPRA.

Section 4.2 Dosage and Administration – update from ‘4 times daily’ to ‘1-2 times daily’ , addition of information ‘not to use after 4 weeks’, addition of other information to bring in line with GDS.

Section 4.4 warnings and precautions – Addition of minor information and to bring in line with GDS, other minor editorial updates.

Section 4.6, Fertility, pregnancy and lactation – Addition of minor information and to bring in line with GDS, other minor editorial updates.

Section 4.8 Undesirable effects - Updated to include the QRD version 9 update addition of the ‘Reporting of side effects’.

Section 4.9 overdose – Additional information under ‘Symptoms and signs’, minor QRD updates

Section 5.1, 5.2, 5.3 Clinical Pharmacology and Non-clinical sections – Sections have been completed in line with GDS.

Section 4.3 Contraindications, Section 4.5 Interactions, Section 6.1 list of excipients, Section 6.5 Nature and contents of container, Section 6.6 Special precautions for disposal and other handling – minor editorial and formatting updates

Section 10 – Approval date added

Updated on 11 August 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 17 July 2015

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)

Free text change information supplied by the pharmaceutical company

Change to address of the MA Holder

Updated on 16 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 13 February 2013

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.2 - Posology and method of administration,
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects,
Section 4.9 - Overdose

 

Updated on 13 February 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 23 July 2012

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 26 August 2008

Reasons for updating

  • Improved electronic presentation

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

Updated on 22 March 2007

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 09 March 2007

Reasons for updating

  • Improved electronic presentation

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

Updated on 04 August 2005

Reasons for updating

  • Improved electronic presentation

Updated on 11 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

Reasons for updating

  • Improved electronic presentation

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

Updated on 08 July 2003

Reasons for updating

  • New SPC for medicines.ie

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