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: 16/10/18
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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 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 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 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 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 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 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 PIL
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
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 30 August 2006 PIL
Reasons for updating
- New SPC for medicines.ie
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)