ALDARA 5% CREAM
- Name:
ALDARA 5% 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: 04/06/19
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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 4 June 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 1 August 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 1 August 2018 SPC
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 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 19 December 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 19 December 2016 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.2: Information regarding the posology for actinic keratosis has changed.
In section 4.4: Information regarding the treatment of actinic keratosis has been added.
In section 5.1: Data regarding two open-label, randomised, controlled clinical trials has been added.
In section 10: The date of revision has changed. Please note that this does not be listed on a centralised product SmPC.
Updated on 19 December 2016 PIL
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.2: Information regarding the posology for actinic keratosis has changed.
In section 4.4: Information regarding the treatment of actinic keratosis has been added.
In section 5.1: Data regarding two open-label, randomised, controlled clinical trials has been added.
In section 10: The date of revision has changed. Please note that this does not be listed on a centralised product SmPC.
Updated on 9 February 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- 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 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: Information regarding the excipients have been expanded to include quantitative data
In section 4.2: Minor text corrections have been made
In section 4.4: Sub-title has been corrected to QRD. Additional warnings regarding the excipients have been included.
In section 4.6: Sub-title has been corrected to QRD. Pregnancy and breast-feeding have been sub-divided within the section
In section 4.7: Information regarding effects on the ability to drive and use machines has been changed.
In section 4.8: Adverse reaction reporting statement has been added
In section 5.1: Paediatric patients now referred to as paediatric population in the sub-title
In section 5.2: Paediatric patients now referred to as paediatric population in the sub-title
In section 10: Date of revision has changed
Updated on 9 February 2015 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- 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 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 2: Information regarding the excipients have been expanded to include quantitative data
In section 4.2: Minor text corrections have been made
In section 4.4: Sub-title has been corrected to QRD. Additional warnings regarding the excipients have been included.
In section 4.6: Sub-title has been corrected to QRD. Pregnancy and breast-feeding have been sub-divided within the section
In section 4.7: Information regarding effects on the ability to drive and use machines has been changed.
In section 4.8: Adverse reaction reporting statement has been added
In section 5.1: Paediatric patients now referred to as paediatric population in the sub-title
In section 5.2: Paediatric patients now referred to as paediatric population in the sub-title
In section 10: Date of revision has changed
Updated on 25 May 2010 SPC
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
In section 4.8 (undesirable effects) the following text has been added:
e) Paediatric patients:
Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 5.1). There was no evidence for systemic reactions. Application site reactions occurred more frequently after imiquimod than after vehicle, however, incidence and intensity of these reactions were not different from that seen in the licensed indications in adults. There was no evidence for serious adverse reaction caused by imiquimod in paediatric patients.
In section 10 the date of revision has been changed
Updated on 25 May 2010 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 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects) the following text has been added:
e) Paediatric patients:
Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 5.1). There was no evidence for systemic reactions. Application site reactions occurred more frequently after imiquimod than after vehicle, however, incidence and intensity of these reactions were not different from that seen in the licensed indications in adults. There was no evidence for serious adverse reaction caused by imiquimod in paediatric patients.
In section 10 the date of revision has been changed
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 SPC
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 30 April 2007 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 30 April 2007 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 February 2007 PIL
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Free text change information supplied by the pharmaceutical company
Updated on 27 February 2007 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 6 September 2006 PIL
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 6 September 2006 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2006 SPC
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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2006 PIL
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
Free text change information supplied by the pharmaceutical company
Updated on 10 May 2006 SPC
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 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 May 2006 PIL
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 4.8 - Undesirable effects
Updated on 4 August 2004 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 August 2004 PIL
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Updated on 29 March 2004 PIL
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Updated on 29 March 2004 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 30 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 30 June 2003 PIL
Reasons for updating
- New SPC for medicines.ie