Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Meda AB, Pipers väg 2A, 170 73, Solna, Sweden
ALDARA 5% cream.
| Pharmaceutical Form |
|---|
|
Cream. White to slightly yellow cream. |
Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5%). 100 mg of cream contains 5 mg of imiquimod.
Excipients with known effects:
Methyl hydroxybenzoate (E218) 2.0 mg/g cream
Propyl hydroxybenzoate (E216) 0.2 mg/g cream
Cetyl alcohol 22.0 mg/g cream
Stearyl alcohol 31.0 mg/g cream
Benzyl alcohol 20.0 mg/g cream
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Imiquimod |
Imiquimod is an immune response modifier. Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells. Imiquimod has no direct antiviral activity. |
| List of Excipients |
|---|
|
Isostearic acid |
Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream.
Not all pack sizes may be marketed.
Meda AB, Pipers väg 2A, 170 73, Solna, Sweden
EU/1/98/080/001-002
Date of first authorisation: 18/09/1998
Date of last renewal: 03/09/2008
| Drug | Countries | |
|---|---|---|
| ALDARA | Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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