Efudix 5% Cream
- Name:
Efudix 5% Cream
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/09/20
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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 1 September 2020 SmPC
Reasons for updating
- 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 not be renewed (A)
Updated on 1 September 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 16 October 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 16 October 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 not be renewed (A)
Updated on 17 June 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 June 2016 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 2: s mall text change has been made
In section 4.2: large change to the posology. Addition of posology for malignant conditions and older people has been added. Method of administration has been added.
In section 4.3: Contraindications have been changed
In section 4.4: Additional special warnings and precautions for use has been added.
In section 4.5: Info5rmation regarding interaction with other medicinal products and other forms of interaction has been added.
In section 4.6: Information regarding pregnancy, breast-feeding and fertility has been added.
In section 4.7: Information regarding effects on ability to drive and use machines has been added.
In section 4.8: Undesirable effects have been added. New information added.
In section 5.1: Pharmacotherapeutic group and ATC code added.
In section 5.2: New information regarding pharmacokinetic properties has been added.
In section 5.3: Information regarding preclinical safety data has been added.
In section 10: The date of revision has been changed.
Updated on 17 June 2016 PIL
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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 2: s mall text change has been made
In section 4.2: large change to the posology. Addition of posology for malignant conditions and older people has been added. Method of administration has been added.
In section 4.3: Contraindications have been changed
In section 4.4: Additional special warnings and precautions for use has been added.
In section 4.5: Info5rmation regarding interaction with other medicinal products and other forms of interaction has been added.
In section 4.6: Information regarding pregnancy, breast-feeding and fertility has been added.
In section 4.7: Information regarding effects on ability to drive and use machines has been added.
In section 4.8: Undesirable effects have been added. New information added.
In section 5.1: Pharmacotherapeutic group and ATC code added.
In section 5.2: New information regarding pharmacokinetic properties has been added.
In section 5.3: Information regarding preclinical safety data has been added.
In section 10: The date of revision has been changed.
Updated on 10 July 2015 SmPC
Reasons for updating
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 July 2015 PIL
Reasons for updating
- 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
Updated on 25 August 2011 PIL
Reasons for updating
- Change to product name
- Change to section 1 - Name of medicinal product
- Change to section 7 - Marketing authorisation holder
- 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 1; name of product has changed to 5% w/w crea,
In section 7; the name and address of the MA Holder has changed
In section 8; the marketing authorisation number has changed to PA1332/32/1
In section 9; the date of last renewal has changed to 1st April 2009
In section 10; the date of revision has changed to August 2011
Updated on 25 August 2011 SmPC
Reasons for updating
- Change to product name
- Change to section 1 - Name of medicinal product
- Change to section 7 - Marketing authorisation holder
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 1; name of product has changed to 5% w/w crea,
In section 7; the name and address of the MA Holder has changed
In section 8; the marketing authorisation number has changed to PA1332/32/1
In section 9; the date of last renewal has changed to 1st April 2009
In section 10; the date of revision has changed to August 2011
Updated on 23 April 2008 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 April 2008 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 20 July 2007 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 July 2007 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Free text change information supplied by the pharmaceutical company
Updated on 30 August 2006 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 August 2006 PIL
Reasons for updating
- New SPC for medicines.ie