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Category B Form - Special Access Scheme

Form no. 2950 (0405)PLEASE USE BLACK PEN, PRINT CLEARLY AND COMPLETE ALL SECTIONSP atient detailsPatient s initials:DOB:MRN:SEX:DiagnosisPrevious SAS No.(if applicable)Clinical justificationfor use of productInclude appraisal ofseriousness of patient'scondition; detailprevious treatments andexpected benefits fromuse of the productProduct detailsAttach efficacy and safety data to support proposed use of the product and details of intended *Complete for medicines *ingredientTrade name/Device nameCompany/supplier(State if imported)Dose form*Route of administration*Dosage*Duration of treatmentDate of medical device procedure/usePrescribing doctor detailsNameInitial SurnameHospitalPostal address (hospital or private).

Title: Category B Form - Special Access Scheme Author: Therapeutic Goods Administration Subject: unapproved therapeutic goods Keywords: special access scheme, medicines, medical devices, australia

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Transcription of Category B Form - Special Access Scheme

1 Form no. 2950 (0405)PLEASE USE BLACK PEN, PRINT CLEARLY AND COMPLETE ALL SECTIONSP atient detailsPatient s initials:DOB:MRN:SEX:DiagnosisPrevious SAS No.(if applicable)Clinical justificationfor use of productInclude appraisal ofseriousness of patient'scondition; detailprevious treatments andexpected benefits fromuse of the productProduct detailsAttach efficacy and safety data to support proposed use of the product and details of intended *Complete for medicines *ingredientTrade name/Device nameCompany/supplier(State if imported)Dose form*Route of administration*Dosage*Duration of treatmentDate of medical device procedure/usePrescribing doctor detailsNameInitial SurnameHospitalPostal address (hospital or private).

2 The approval letter will be mailed to this PostcodeFax numberSignature& date / /Fax (medicines): 02 6232 8112 Fax (medical devices): 02 6232 8785 Mail: SAS Officer, TGA, PO Box 100, Woden ACT 2606 Category B FORMSPECIAL Access Scheme


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