Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p49
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 49/191)
Character Range: 10032321–10046292

exception of stricture, which can be attributable to eosinophilic oesophagitis; and
                                                                                                                                                                                                                               (iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
                                                                                                                                                                                                                               The date of birth of the patient must be included in the authority application.
C5947               P5947          CN5947           Famciclovir                                                                                                                                                                Recurrent moderate to severe oral or labial herpes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 5947
                                                                                                                                                                                                                               Episodic treatment
                                                                                                                                                                                                                               Patient must have HIV infection; AND
                                                                                                                                                                                                                               Patient must have a CD4 cell count of less than 500 million per litre.
                                                                                                                                                                                                                               Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
C5948               P5948          CN5948           Famciclovir                                                                                                                                                                Recurrent moderate to severe oral or labial herpes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 5948
                                                                                                                                                                                                                               Suppressive therapy
                                                                                                                                                                                                                               Patient must have HIV infection; AND
                                                                                                                                                                                                                               Patient must have CD4 cell counts of less than 150 million per litre.
                                                                                                                                                                                                                               Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
C5949               P5949          CN5949           Famciclovir                                                                                                                                                                Recurrent moderate to severe oral or labial herpes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 5949
                                                                                                                                                                                                                               Suppressive therapy
                                                                                                                                                                                                                               Patient must have HIV infection; AND
                                                                                                                                                                                                                               Patient must present with other opportunistic infections or AIDS defining tumours.
                                                                                                                                                                                                                               Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
C5950               P5950          CN5950           Nitrazepam                                                                                                                                                                 Insomnia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must be receiving this drug for the management of insomnia; AND
                                                    Temazepam                                                                                                                                                                  Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND
                                                                                                                                                                                                                               Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
C5951               P5951          CN5951           Famciclovir                                                                                                                                                                Herpes zoster                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 5951
                                                                                                                                                                                                                               The treatment must be administered within 72 hours of the onset of the rash.
C5954               P5954          CN5954           Famciclovir                                                                                                                                                                Recurrent moderate to severe genital herpes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 5954
                                                                                                                                                                                                                               Episodic treatment or suppressive therapy
                                                                                                                                                                                                                               Patient must be immunocompromised.
                                                                                                                                                                                                                               Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
C5959               P5959          CN5959           Aciclovir                                                                                                                                                                  Herpes zoster ophthalmicus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 5959

C5960               P5960          CN5960           Valaciclovir                                                                                                                                                               Initial moderate to severe genital herpes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority