Eumovate Ointment
- Name:
Eumovate Ointment
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/18
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 13/12/2017
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
GlaxoSmithKline (Ireland) Ltd
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Company Products
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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 26 November 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 13 December 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 13 December 2017 SmPC
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
Section 4.8 - Undesirable effects - added blurred vision
Updated on 13 December 2017 PIL
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 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 1 September 2016 SmPC
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
• 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 PIL
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 SmPC
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
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 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 13 February 2013 SmPC
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
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 PIL
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 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 26 August 2008 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 22 March 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 9 March 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 August 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 11 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 9 August 2004 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 8 July 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)