Zyclara 3.75% cream
- Name:
Zyclara 3.75% cream
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Print ViewKeyword Search SmPC
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
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 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
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
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
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
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
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)