Eumovate Cream
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
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 07 July 2022
File name
ie-pl-eumovatecream-issue9draft1_CLEAN-meds.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 01 September 2021
File name
ie-pl-eumovatecream-issue8draft1_clean-meds.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 10 March 2021
File name
ie-spc-eumovatecream-issue5draft1_clean-meds.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 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)
Updated on 10 March 2021
File name
ie-pl-eumovatecream-issue7draft1_clean-meds.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
Updated on 12 February 2021
File name
ie-pl-eumovatecream-issue6draft1-clean-medsie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 November 2018
File name
ie-pl-eumovatecream-issue5draft1 - Meds ie.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 13 December 2017
File name
PIL_8188_638.pdf
Reasons for updating
- New PIL for new product
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
- 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
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
• 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 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 - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- 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 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
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- 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
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 29 June 2005
Reasons for updating
- Improved electronic presentation
Updated on 11 August 2004
Reasons for updating
- New PIL for medicines.ie
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)