Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p297
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 297/312)
Character Range: 17358214–17366518

level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.
                                                                                                                           Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.
                                                                                                                           For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.
                                                                                                                           Access to this drug through this restriction is permitted irrespective of vaccination status.
                                                                                                                           Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
                                                                                                                           Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
                                                                                                                           This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
                                                                                                                           For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
                                                                                                                           Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.
C16204              P16204         CN16204          Testosterone                                                           Micropenis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
                                                                                                                           The treatment must be applied to the scrotum, where possible.
                                                                                                                           The name of the specialist must be included in the authority application.
C16206              P16206         CN16206          Testosterone                                                           Micropenis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
                                                                                                                           The treatment must be applied to the scrotum, where possible.
                                                                                                                           The name of the specialist must be included in the authority application.
C16207              P16207         CN16207          Testosterone                                                           Pubertal induction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
                                                                                                                           Patient must be under 18 years of