Zyclara 3.75% cream

  • Name:

    Zyclara 3.75% cream

  • Company:
    info
  • Active Ingredients:

    Imiquimod

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 21/2/2018
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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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26 - 50 of 97 items.Total: 4 pages

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 21 February 2018 PIL

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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

$0In section2: Benzyl alcohol 20.0mg/g cream added$0$0In section4.4: Warning added that benzyl alcohol may cause allergic reactions and mildlocal irritation$0$0In section4.8: Abdominal pain added as a uncommon undesirable effect undergastrointestinal disorders$0In section 10: Dateof revision changed

Updated on 21 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 21 February 2018 SmPC

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 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

$0In section2: Benzyl alcohol 20.0mg/g cream added$0$0In section4.4: Warning added that benzyl alcohol may cause allergic reactions and mildlocal irritation$0$0In section4.8: Abdominal pain added as a uncommon undesirable effect undergastrointestinal disorders$0In section 10: Dateof revision changed

Updated on 28 December 2017 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

$0In section4.3: Information added with regards recommendation of different therapy if thetreated lesion(s) show(s) insufficient response to Zyclara.$0$0In section4.4: Minor rewording of text.$0$0In section5.1: Information added regarding two open-label randomized, controlledstudies investigated the long-term effects of imiquimod 5% (and not with this3.75% product) in comparison to topical diclofenac (3% gel).$0$0In section10: Date of revision changed.$0

Updated on 28 December 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

$0In section4.3: Information added with regards recommendation of different therapy if thetreated lesion(s) show(s) insufficient response to Zyclara.$0$0In section4.4: Minor rewording of text.$0$0In section5.1: Information added regarding two open-label randomized, controlledstudies investigated the long-term effects of imiquimod 5% (and not with this3.75% product) in comparison to topical diclofenac (3% gel).$0$0In section10: Date of revision changed.$0

Updated on 18 April 2017 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 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 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: Reference to treatment being initiated by a physician has been removed. Information regarding hepatic or renal impairment has been added.

In section 4.4: Information has been removed regarding no available data on use of Imiquimod for the treatment of AK in anatomical areas other than face and scalp. Information added to systemic reactions and special populations.

In section 4.5: slight text changes.

In section 4.6: Information added regarding breast-feeding

In section 4.8: Information added to adverse reactions – summary of safety profile

In section 4.9: Information added regarding management of overdose

In section 5.1: Information added regarding paediatric population

In section 9: Information added regards date of last renewal

In section 10: The date of revision has been changed.

Updated on 18 April 2017 SmPC

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 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 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the 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 4.2: Reference to treatment being initiated by a physician has been removed. Information regarding hepatic or renal impairment has been added.

In section 4.4: Information has been removed regarding no available data on use of Imiquimod for the treatment of AK in anatomical areas other than face and scalp. Information added to systemic reactions and special populations.

In section 4.5: slight text changes.

In section 4.6: Information added regarding breast-feeding

In section 4.8: Information added to adverse reactions – summary of safety profile

In section 4.9: Information added regarding management of overdose

In section 5.1: Information added regarding paediatric population

In section 9: Information added regards date of last renewal

In section 10: The date of revision has been changed.

Updated on 9 February 2015 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • 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 4.4: The sub-title has been corrected to the QRD template

In section 4.5: A minor text change has been made

In section 4.8: The adverse reaction reporting statement has been added

In section 5.1: The sub-title has been corrected

In section 5.2: Very minor layout changes have been made

In section 8: The marketing authorisation numbers are expanded

In section 9: The date of first authorisation has been corrected

In section 10: The date of revision has been changed

Updated on 9 February 2015 SmPC

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • 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 4.4: The sub-title has been corrected to the QRD template

In section 4.5: A minor text change has been made

In section 4.8: The adverse reaction reporting statement has been added

In section 5.1: The sub-title has been corrected

In section 5.2: Very minor layout changes have been made

In section 8: The marketing authorisation numbers are expanded

In section 9: The date of first authorisation has been corrected

In section 10: The date of revision has been changed

Updated on 6 November 2013 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 6 November 2013 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided