| Document Date: 2014-06-19 10:56:32
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City Wehr / / Company AEs / Valeant Pharmaceuticals North America LLC / Novartis Pharma Produktions GmbH / Ames / MEDA Pharma S.A.R.L. / Distribution Laboratory / / Country Germany / Luxembourg / / Event FDA Phase / / Facility I store ELIDEL Cream / / IndustryTerm healthcare / otitis media / / MedicalCondition neoplasms / Molluscum Contagiosum / eczema herpeticum / basal cell carcinoma / atopic dermatitis / viral infection / skin papilloma / lymphoma / warts / headache / cutaneous infections / generalized erythroderma / Chickenpox / flu / common cold / shingles / lymphoproliferative disorder / ocular irritation / cumulative irritation / chicken pox / dermatitis / skin cancer / Nausea / cold sores / herpes / rhinitis / impetigo / skin papillomas / Arthralgias / Netherton’s Syndrome / septic arthritis / Injury / lymphadenopathy / hypersensitivity / Anaphylactic reactions / diarrhea / Sinusitis / otitis media / Constipation / short-term and non-continuous chronic treatment / pruritus / thymoma / infections / influenza / wheezing / cancers / Sore Throat / tumor / adenoma / Epistaxis / cutaneous T-cell lymphoma / squamous cell carcinoma / cancer / opportunistic infections / skin infection / tumors / Bacterial and Viral Skin Infections / disease / nasopharyngitis / gastroenteritis / pyrexia and viral infection / Carcinogenesis / phototoxicity / chronic / acute infectious mononucleosis / Folliculitis / eczema / Nasal Congestion / lymphomas / erythema / itching / fever / superinfection / malignant melanoma / skin disease / viral infections / uperficial skin infections / vomiting / Staphylococcal Infection / lymphadenopathy resolves / Toothache / urticaria / Bacterial Infection / erythrodermic disease / skin flushing / infection / irritation / cough / varicella zoster virus infection / rash / pharyngitis / Herpes Simplex / skin diseases / herpes simplex virus infection / syndrome / inflammatory / angioneurotic edema / / MedicalTreatment light therapy / immunizations / radiation / Immunosuppression / immunosuppressive therapy / antibiotic therapy / / Organization World Health Organization / U.S. Food and Drug Administration / DOSAGE AND ADMINISTRATION / FDA / / / Position pharmacist / physician / General / Major / pharmacist for more information / / Product itraconazole / erythromycin / cimetidine / ELIDEL / fluconazole / ketoconazole / ELIDEL Cream / pediatric / / ProvinceOrState New Jersey / / Region Germany U.S. / / Technology radiation / drug metabolism / transplantation / Pharmacokinetics / / URL www.fda.gov/medwatch / www.Elidel.com / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ELIDEL® safely and effectively. See full prescribing information for ELIDEL®. ELIDEL® (pimecrolimus) Cream, 1% fo