DIFFLAM 3% CREAM
- Name:
DIFFLAM 3% CREAM
- Company:
Mylan IRE Healthcare Limited
- 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: 06/12/18
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Mylan IRE Healthcare Limited
Company Products
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 6 December 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 5 December 2018 SmPC
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: Product subject to medical prescription which may be renewed (B)
Updated on 24 October 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 24 October 2016 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
In section 4.8: The ADR statement has been updated. Slight text amendment.
In section 10: The date of revision
Updated on 24 October 2016 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.8: The ADR statement has been updated. Slight text amendment.
In section 10: The date of revision
Updated on 29 May 2014 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 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
In section 4.4: these has been additional warnings added in relation to allergic reactions and to bronchospasm
In section 4.8: additional side effect of anaphylactic reaction has been added. Reporting information of adverse reaction to the IMB has been added
In section 5.1: Change in pharmacotherapeutic group. Additional information regarding the mode of action added. Pharmacodynamic effect information has been added. Clinical efficacy and safety text added.
In section 10: the date of revision has changed.
Updated on 29 May 2014 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.4: these has been additional warnings added in relation to allergic reactions and to bronchospasm
In section 4.8: additional side effect of anaphylactic reaction has been added. Reporting information of adverse reaction to the IMB has been added
In section 5.1: Change in pharmacotherapeutic group. Additional information regarding the mode of action added. Pharmacodynamic effect information has been added. Clinical efficacy and safety text added.
In section 10: the date of revision has changed.
Updated on 19 August 2013 PIL
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.3: The contraindications has been expanded to include the name of the active ingredient and a reference to the other ingredients.
In section 4.4: Addition warning regarding methyl hydroxybenzoate and propyl hydroxybenzoate has been added. Reference to delayed allergic reactions.
In section 4.6: Addition information has been added in relation to the use in pregnancy & lactation
In section 4.8: The format listing side effects has changed.
In section 5.1: The ATC Code has changed
In section 5.3: Additional data has been entered with respect to Non-Clinical Data.
In section 10: The date of revision has been changed.
Updated on 19 August 2013 SmPC
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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
In section 4.3: The contraindications has been expanded to include the name of the active ingredient and a reference to the other ingredients.
In section 4.4: Addition warning regarding methyl hydroxybenzoate and propyl hydroxybenzoate has been added. Reference to delayed allergic reactions.
In section 4.6: Addition information has been added in relation to the use in pregnancy & lactation
In section 4.8: The format listing side effects has changed.
In section 5.1: The ATC Code has changed
In section 5.3: Additional data has been entered with respect to Non-Clinical Data.
In section 10: The date of revision has been changed.
Updated on 20 February 2013 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
· In section 6.1: there has been a change to the excipients
· In section 10: the date of revision has changed
Updated on 20 February 2013 SmPC
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
· In section 6.1: there has been a change to the excipients
· In section 10: the date of revision has changed
Updated on 15 August 2011 PIL
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 7 - Marketing authorisation holder
- 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
In section 2; Additional information regarding the composition has been added
In section 6.1; (Macrogol Cetostearyl Ether) has been added in brackets
In section 6.4; the storage conditions have changed. The temp is reduced from 30 degrees to 25 degrees. there is additional information added 'Keep the lid tightly closed'.
In section 7; the address of the MA holder has changed
In section 8; the date of last renewal has been updated to the 05 September 2008
In section 10; the date of revision has been changed to July 2011
Updated on 15 August 2011 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
- 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
In section 2; Additional information regarding the composition has been added
In section 6.1; (Macrogol Cetostearyl Ether) has been added in brackets
In section 6.4; the storage conditions have changed. The temp is reduced from 30 degrees to 25 degrees. there is additional information added 'Keep the lid tightly closed'.
In section 7; the address of the MA holder has changed
In section 8; the date of last renewal has been updated to the 05 September 2008
In section 10; the date of revision has been changed to July 2011
Updated on 11 April 2011 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
in section 6.1; the full name of 2 excipients have been added
in section 9; the date of first authorisation has been corrected
In section 1; change to the title to reflect the full name as listed in the SPC
Updated on 11 April 2011 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
in section 6.1; the full name of 2 excipients have been added
in section 9; the date of first authorisation has been corrected
In section 1; change to the title to reflect the full name as listed in the SPC
Updated on 14 April 2009 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 14 April 2009 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 January 2004 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 January 2004 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
Updated on 4 June 2003 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 June 2003 PIL
Reasons for updating
- New SPC for new product