Aldara 5% cream *
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Legal 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

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 04 June 2019

File name

ie-pl-h179-clean-v074_1559657263.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 01 August 2018

File name

ie-pl-h179en clean-aldara n-72_1533139798.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 August 2018

File name

ie-spc-h179en clean-aldara n-72_1533139901.pdf

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

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

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

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 09 February 2015

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 09 February 2015

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

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 4.4 (Special warnings and special precautions for use) the following text has been removed:  "As data on long-term clearance rates beyond 36 months post-treatment are not currently available, other appropriate therapeutic modalities should be considered for sBCC

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

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 4.4 (Special warnings and special precautions for use) the following text has been removed:  "As data on long-term clearance rates beyond 36 months post-treatment are not currently available, other appropriate therapeutic modalities should be considered for sBCC

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

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7 change of marketing authorisation holder

Updated on 14 April 2009

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

Section 7 change of marketing authorisation holder

Updated on 30 April 2007

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

4.4 statement concerning broken skin added
 
5.1  4 year sBCC recurrence data

Updated on 30 April 2007

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

4.4 statement concerning broken skin added
 
5.1  4 year sBCC recurrence data

Updated on 27 February 2007

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Free text change information supplied by the pharmaceutical company

 
4.1 Therapeutic indications
 
Aldara 5% Cream is now indicated for AK (Actinic keratoses) on the face and scalp.

Updated on 27 February 2007

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

 
4.1 Therapeutic indications
 
Aldara 5% Cream is now indicated for AK (Actinic keratoses) on the face and scalp.

Updated on 06 September 2006

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

 
5.1 BCC clearance rates updated from 2 to 3 years 

Updated on 06 September 2006

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

 
5.1 BCC clearance rates updated from 2 to 3 years 

Updated on 23 August 2006

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

 
4.4 Special Warnings - section revamped
 
4.5  Interactions with other medicinal products - includes statement re caution in patients who are receiving immuno suppressive medication

Updated on 23 August 2006

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

 
4.4 Special Warnings - section revamped
 
4.5  Interactions with other medicinal products - includes statement re caution in patients who are receiving immuno suppressive medication

Updated on 10 May 2006

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

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 04 August 2004

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 August 2004

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Updated on 29 March 2004

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Updated on 29 March 2004

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

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

Reasons for updating

  • New SPC for medicines.ie