METVIX Cream Ref.[9113] Active ingredients: Methyl aminolevulinate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, United Kingdom

Product name and form

Metvix 160 mg/g cream.

Pharmaceutical Form

Cream.

The colour is cream to pale yellow.

Qualitative and quantitative composition

Metvix contains 160 mg/g of methyl aminolevulinate (as hydrochloride) equivalent to 16.0% of methyl aminolevulinate (as hydrochloride).

Excipients with known effect: Metvix contains cetostearyl alcohol (40 mg/g), methyl parahydroxybenzoate (E218; 2 mg/g), propyl parahydroxybenzoate (E216; 1 mg/g) and arachis oil (30 mg/g).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methyl aminolevulinate

Methyl aminolevulinate is a prodrug that is metabolized to protoporphyrin. After topical application of methyl aminolevulinate, porphyrins accumulate intracellularly in the treated skin lesions. The intracellular porphyrins (including PpIX) are photoactive, fluorescing compounds and, upon light activation in the presence of oxygen, singlet oxygen is formed which causes damage to cellular compartments, in particular the mitochondria. Light activation of accumulated porphyrins leads to a photochemical reaction and thereby phototoxicity to the light-exposed target cells.

List of Excipients

Self-emulsifying glyceryl monostearate
Cetostearyl alcohol
Poloxyl 40 stearate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Disodium edetate
Glycerol
White soft paraffin
Cholesterol
Isopropyl myristate
Arachis oil
Refined almond oil
Oleyl alcohol
Purified water

Pack sizes and marketing

Aluminium tube with internal protective lacquer and a latex seal. Screw cap of HDPE.

Metvix cream is supplied in a tube containing 1g or 2 g cream. Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, United Kingdom

Marketing authorization dates and numbers

PL 10590/0048

20/07/2006

Drugs

Drug Countries
METVIX Austria, Brazil, Canada, Spain, Finland, Ireland, Malta, Netherlands, New Zealand, Singapore, United Kingdom, South Africa

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