Pimecrolimus

Treatment of patients 3 months of age and older with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible. This may include: • Intolerance to topical corticosteroids • Lack of effect of topical corticosteroids • Use on the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate

ELIDEL (pimecrolimus) Cream 1% is indicated for:  second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients 3 months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.

For additional safety information, please refer to WARNINGS AND PRECAUTIONS section. 1 Pediatrics Pediatrics ( 3 months of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ELIDEL cream in pediatric patients have been established; therefore, Health Canada has authorized an indication for pediatric use.

2 Geriatrics Geriatrics (> 65 years of age): Clinical studies of ELIDEL did not include sufficient numbers of subjects aged 65 and older to establish efficacy and safety of the drug in geriatric patients.