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
Metvix 160 mg/g cream.
| Pharmaceutical Form |
|---|
|
Cream. The colour is cream to pale yellow. |
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 |
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.
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, United Kingdom
PL 10590/0048
20/07/2006
| Drug | Countries | |
|---|---|---|
| METVIX | Austria, Brazil, Canada, Spain, Finland, Ireland, Malta, Netherlands, New Zealand, Singapore, United Kingdom, South Africa |
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