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Efudix 5% Cream

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Fluorouracil

    *Additional information is available within the SPC or upon request to the company

Updated on 04 July 2024

File name

ie-pl-efudix-MAHT-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 04 July 2024

File name

ie-spc-efudix-MAHT-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 21 November 2023

File name

ie-pl-efudix-pr2681211-2576268-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 21 November 2023

File name

ie-spc-efudix-pr2681211-2576268-RFI-27OCT2023-clean .pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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)

Updated on 21 November 2023

File name

ie-pl-efudix-pr2681211-2576268-clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 21 November 2023

File name

ie-pl-efudix-pr2681211-2576268-clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 25 November 2022

File name

ie-mt-pl-efudix-pr2681211-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 25 November 2022

File name

ie-spc-efudix-pr2681211rtq-clean.pdf

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 5.3 - Preclinical safety data

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

Updated on 04 February 2022

File name

ie-mt-pl-efudix-pr2576268rtq-clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 04 February 2022

File name

ie-spc-efudix-pr2576268-clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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)

Updated on 01 September 2020

File name

ie-spc-efudix-clean-prac2176173.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.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.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 October 2018

File name

ie-spc-efudix-clean-mahtransfer.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

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 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 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