EFUDIX Cream Ref.[7973] Active ingredients: Fluorouracil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Efudix 5% cream.

Pharmaceutical Form

White, opaque cream.

Qualitative and quantitative composition

Efudix cream contains 5% w/w fluorouracil.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluorouracil

Fluorouracil is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine – which become the building blocks of DNA. They prevent these substances from becoming incorporated into DNA during the “S” phase (of the cell cycle), stopping normal development and division. Fluorouracil blocks an enzyme which converts the cytosine nucleotide into the deoxy derivative. In addition, DNA synthesis is further inhibited because Fluorouracil blocks the incorporation of the thymidine nucleotide into the DNA strand. Fluorouracil is used for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

List of Excipients

Stearyl alcohol
White soft paraffin
Polysorbate 60
Propylene glycol
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Purified water

Pack sizes and marketing

Efudix cream is supplied in a 20g and a 40g aluminium tube with a plastic screw cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0128

22/07/2008

Drugs

Drug Countries
EFUDIX Australia, Estonia, France, Ireland, Israel, Malta, Mexico, Netherlands, New Zealand, Poland, Turkey, United Kingdom, South Africa

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