Efudix 5% Cream *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • 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 01 September 2020

File name

ie-spc-efudix-clean-prac2176173_1598987046.pdf

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 01 September 2020

File name

ie-pl-efudix-clean-prac2176173_1598987021.pdf

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

File name

ie-pl-efudix-mahtransfer-clean_1539695397.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 October 2018

File name

ie-spc-efudix-clean-mahtransfer_1539695429.pdf

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

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 June 2016

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

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

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

In section 4.8: ADR statement has been added$0In section 10: Date of revision has changed$0

Updated on 10 July 2015

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

In section 4.8: ADR statement has been added$0In section 10: Date of revision has changed$0

Updated on 25 August 2011

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

Name of product has changed to Efudix 5%w/w cream

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

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

Name of product has changed to Efudix 5%w/w cream

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

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

Section 2: Excipients have been added:
  11.5%              propylene glycol (E1520)
  0.025%            methyl parahydroxybenzoate (E218)
 0.015% propyl parahydroxybenzoate (E216)
 
Section 6.3  New guidelines for the shelf life, including the new 5 g pack.
 
 Shelf life after first opening the immediate packaging:      28 days for the 5g tube, 90 days for the 20g and 40g tubes
 
Section 6.5  Additional information on the container, including the new 5 g pack
Efudix cream is packed in 40g, 20g and 5g aluminium membrane-sealed tubes, coated inside with an epoxy phenolic resin derivative lacquer.  The tube is closed with a polypropylene PP membrane piercing cap.
 

Updated on 23 April 2008

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

Section 2: Excipients have been added:
  11.5%              propylene glycol (E1520)
  0.025%            methyl parahydroxybenzoate (E218)
 0.015% propyl parahydroxybenzoate (E216)
 
Section 6.3  New guidelines for the shelf life, including the new 5 g pack.
 
 Shelf life after first opening the immediate packaging:      28 days for the 5g tube, 90 days for the 20g and 40g tubes
 
Section 6.5  Additional information on the container, including the new 5 g pack
Efudix cream is packed in 40g, 20g and 5g aluminium membrane-sealed tubes, coated inside with an epoxy phenolic resin derivative lacquer.  The tube is closed with a polypropylene PP membrane piercing cap.
 

Updated on 20 July 2007

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

To include a quantitative declaration for stearyl alcohol in Section 2 of the SPC.

Updated on 20 July 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Free text change information supplied by the pharmaceutical company

To include a quantitative declaration for stearyl alcohol in Section 2 of the SPC.

Updated on 30 August 2006

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

Reasons for updating

  • New SPC for medicines.ie