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Oncology / Lymphoma / Type 1 hypersensitivity / Pimecrolimus / Tacrolimus / Calcineurin / Atopy / Atopic dermatitis / Adverse Event Reporting System / Medicine / Immunosuppressants / Macrolides


DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD[removed]DATE:
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Document Date: 2005-02-11 16:14:03

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File Size: 171,66 KB

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Company

Spontaneous Surveillance Systems / Goldman SA / DDDDP / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

spontaneous reporting systems / search terms / drug product / spontaneous systems / spontaneous adverse event reporting systems / surveillance systems / chemical plant / /

MedicalCondition

later primary lung cancer / herpetic infection / Squamous cell carcinoma B-cell lymphoma / lichen sclerosus / nipple Lymphoma Basal Cell Carcinoma T-Cell lymphoma / atopic dermatitis / lymphoma / Virus-associated malignant large B-Cell lymphoma / lymphoma development / Sezary Syndrome Lymphoma Esophageal cancer / Granuloma / lymphoma Cutaneous Kaposi’s Sarcoma24 Non-Hodgkin / cellulitis / kidney lymphoma / paniculitis like22 Squamous Cell Carcinoma / lymphadenitis / paniculitislike T-cell lymphoma / Incl Cysts / Kaposi’s sarcoma / recurrence Melanoma / Virus-associated large B-cell lymphoma / Malignant B-Cell Lymphoma / lymphoma nos / Squamous Cell Carcinoma T-Cell lymphoma / metastatic Lymphoma / lung tumor / subcutaneous paniculitis-like T-Cell lymphoma / Malignancy Hepatoblastoma Angiosarcoma / tumor / teratoma / squamous cell carcinoma / cancer / low grade squamous cell carcinoma / primary lung cancer / acute hepatitis / hyperplasia Tumor Lymphoma Intraductal papilloma / mild axillary lymphadenopathy / T-cell lymphoma / lymphoma / anaplastic large cell / /

MedicalTreatment

antibiotics / chemotherapy / HAART / /

Organization

office of New Drugs / Food and Drug Administration / Division of Dermatologic and Dental Drug Products / Division of Drug Risk Evaluation / Zocor administration / Dental Drug Products / Deputy Office / Anti-Infective Drugs Advisory Committee / Anti-Infectives Drugs Advisory Committee / DEPARTMENT OF HEALTH / office of Drug Safety / Division of Dermatologic / Postmarketing Safety Evaluator office of Drug Safety / Pediatric Subcommittee / /

Person

Mark Avigan / Jonathan K. Wilkin / Sandy Kweder / Marilyn R. Pitts / Safety Evaluator / Lauren Lee / /

Position

Acting Team Leader / Director / EXECUTIVE / /

Product

Pimecrolimus / Protopic / Elidel / klaron / metronidazole / Prograf / hydrocortisone / Zocor / Reactions / Adverse Drug / /

ProvinceOrState

Maryland / /

Technology

Anti-Infectives / chemotherapy / /

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