Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p165
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 165/381)
Character Range: 12594405–12601516

AN count; and
                                                                                                                                                                    (iii) the name of the antibiotic/s received for two separate courses each of three months; or
                                                                                                                                                                    (iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.
C12349              P12349         CN12349          Beclometasone with formoterol and glycopyrronium                                                                Chronic obstructive pulmonary disease (COPD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12349
                                                                                                                                                                    Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; or
                                                    Budesonide with glycopyrronium and formoterol                                                                   Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition; AND
                                                                                                                                                                    Patient must not be undergoing treatment with this product in each of the following circumstances:
                                                    Fluticasone furoate with umeclidinium and vilanterol                                                             (i) treatment of asthma in the absence of a COPD diagnosis, (ii) initiation of bronchodilator therapy in COPD, (iii) use as reliever therapy for asthma, (iv) dosed at an interval/frequency that differs to that recommended in the approved Product Information.

C12351              P12351         CN12351          Leuprorelin                                                                                                     Central precocious puberty
                                                                                                                                                                    Continuing treatment with this drug, or, switching gonadotropin releasing hormone analogue therapy
                                                    Triptorelin                                                                                                     Must be treated by a medical practitioner identifying as one of:
                                                                                                                                                                     (i) a paediatric endocrinologist, (ii) an endocrinologist specialising in paediatrics; or
                                                                                                                                                                    Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
                                                                                                                                                                    Patient must be undergoing continuing treatment with a gonadotropin releasing hormone analogue initiated through the PBS for this PBS indication.
C12387              P12387         CN12387          Triptorelin                                                                                                     Central precocious puberty
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a paediatric endocrinologist; or
                                                                                                                                                                    Must be treated by an endocrinologist specialising in paediatrics;
                                                                                                                                                                    Patient must be of an age that is prior to their 12th birthday if female; or
                                                                                                                                                                    Patient must be of an age that is prior to their 13th birthday if male;
                                                                                                                                                                    Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if female.  or
                                                                                                                                                                    Patient must have had onset of signs/symptoms of central precocious puberty prior to their 10th