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Meda Pharmaceuticals

Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
Telephone: 0845 460 0000
Fax: 0845 460 0002
Medical Information Direct Line: +44 (0)1748 828 810
Medical Information e-mail: meda@professionalinformation.co.uk
Medical Information Fax: +44 (0)1748 828 801
Out of Hours contact: +44 (0)1748 828 810

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 18/04/2011
SPC Efudix Cream

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 18/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.4. Addition of sentence regarding the reduced activity / deficiency of the of the enzyme DPD
Change to section 6.3. and 6.5. reference to 5g deleted
Updated on 20/09/2010 and displayed until 18/04/2011
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to the following sections of the SPC:

  • Change to section 4.3 Contraindications
  • Change to section 4.4 Special Warnings and precautions for use
  • Change to section 4.5 Interactions
  • Change to section 4.6 Pregnancy and lactation
  • Change to section 4.8 Undesirable effects
  • Change to section 5.3 Preclinical safety data
  • Change to section 6.6 Special precautions for disposal
  • Change to section 10 Date of revision of text

    		•
    Updated on 15/01/2010 and displayed until 20/09/2010
    Reasons for adding or updating:
    • Change to section 6. 3 - Shelf Life
    • Change to section 6. 5 - Nature and Contents of Container
    • Change to section 10 date of revision of the text
    Date of revision of text on the SPC:   01-Jul-2009
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company
    Change to section 6.3: Shelf-life after first opening included under section 6.3
    Change to section 6.5: 5g pack size included under section 6.5
    Date in section 10 updated
    Updated on 26/08/2009 and displayed until 15/01/2010
    Reasons for adding or updating:
    • Change to section 7 - Marketing Authorisation Holder
    • Change to section 10 date of revision of the text
    Date of revision of text on the SPC:   01-Jun-2009
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company
    Change to Sections 7. Marketing Authorisation Holder and 10. Date of Revision of the Text
    Updated on 08/12/2006 and displayed until 26/08/2009
    Reasons for adding or updating:
    • Change to section 6. 5 - Nature and Contents of Container
    • SPC Retired pending re-submission
    Date of revision of text on the SPC:   06/2006
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company
    Section 6.5 Efudix cream is supplied in a 20g and a 40 g aluminium tube with a plastic screw cap
    Updated on 01/08/2005 and displayed until 08/12/2006
    Reasons for adding or updating:
    • Change to section 6.1 - List of Excipients
    Updated on 20/07/2004 and displayed until 01/08/2005
    Reasons for adding or updating:
    • Change to section 7 - Marketing Authorisation Holder
    Updated on 21/08/2001 and displayed until 20/07/2004
    Reasons for adding or updating:
    • Change to section 5.3 - Preclinical Safety Data
    • Change to section 9 - Date of Renewal of Authorisation
    Updated on 07/08/2001 and displayed until 21/08/2001
    Reasons for adding or updating:
    • Change to section 1 - trade name
    • Change to section 6. 6 - Instruction for Use/Handling

    Active Ingredients/Generics

     
      fluorouracil