E45 Cream
*Company:
Karo Pharma ABStatus:
UpdatedLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 February 2023
File name
SmPC 20220930 E45 Cream IE- clean incl HPRA add changes.pdf
Reasons for updating
- 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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
uploading anew to comply with the correct format
Updated on 11 November 2022
File name
SmPC 20220930 E45 Cream IE- clean incl HPRA add changes.pdf
Reasons for updating
- 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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Change to section 7- MAH: From Reckitt to Karo Pharma AB
Change to section 8- MA Number: From PA 979/43/1 to PA 22650/007/001
Change to section 10-Date of revision of text: From Dec 2021 to Sep 2022
Updated on 26 September 2022
File name
IE E45 Cream SPC CRN00CGYV Dec21.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Updated on 26 September 2022
File name
IE E45 Cream SPC CRN00CGYV Dec21.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Updated on 06 December 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 06 December 2016
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section4.4:
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"
Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin. This could potentiate the hypotensive effects of vasodilators"
Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"
Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin. This could potentiate the hypotensive effects of vasodilators"
Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"
Updated on 06 December 2016
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
Free text change information supplied by the pharmaceutical company
Section4.4:
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"
Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin. This could potentiate the hypotensive effects of vasodilators"
Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"
Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin. This could potentiate the hypotensive effects of vasodilators"
Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"
Updated on 14 April 2016
Reasons for updating
- 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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated in line with CCDS
Updated on 14 April 2016
Reasons for updating
- 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
Free text change information supplied by the pharmaceutical company
Updated in line with CCDS
Updated on 17 December 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Addition of babies to section 4.2
Updated on 17 December 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Free text change information supplied by the pharmaceutical company
Addition of babies to section 4.2
Updated on 30 March 2011
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
In section 4.1 (therapeutic indication), "use as emollient adjunctive therapy in the treatment of dry cases of psoriasis" has been added.
In section 10, revison of text date changed to March 2011
In section 10, revison of text date changed to March 2011
Updated on 30 March 2011
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.1 (therapeutic indication), "use as emollient adjunctive therapy in the treatment of dry cases of psoriasis" has been added.
In section 10, revison of text date changed to March 2011
In section 10, revison of text date changed to March 2011
Updated on 05 February 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.6 - Pregnancy and lactation
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
All changes as a result of license renwal
Updated on 05 February 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.6 - Pregnancy and lactation
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
All changes as a result of license renwal
Updated on 21 August 2008
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Update to section 6.5 Nature and Contents of Containers
Updated on 21 August 2008
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Update to section 6.5 Nature and Contents of Containers
Updated on 24 April 2008
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Change to section 6.5 addition of 500g pump pack with pump piston airless dispenser.
Updated on 24 April 2008
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Change to section 6.5 addition of 500g pump pack with pump piston airless dispenser.
Updated on 21 August 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Change of MA holder and PA numer to Reckitt Benckiser Irelang Ltd
Updated on 21 August 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Change of MA holder and PA numer to Reckitt Benckiser Irelang Ltd
Updated on 09 June 2005
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Updated on 09 June 2005
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie