Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p31
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 31/191)
Character Range: 9809116–9822495

metastatic disease.
C5297               P5297          CN5297           Flucloxacillin                                                                                                                                                             Serious staphylococcal infection

C5298               P5298          CN5298           Flucloxacillin                                                                                                                                                             Serious staphylococcal infection

C5323               P5323          CN5323           Amino acid formula with vitamins and minerals without lysine and low in tryptophan                                                                                         Proven glutaric aciduria type 1

C5324               P5324          CN5324           Bisoprolol                                                                                                                                                                 Moderate to severe heart failure
                                                                                                                                                                                                                               Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated.
                                                    Carvedilol

                                                    Metoprolol succinate

                                                    Nebivolol

C5325               P5325          CN5325           Topiramate                                                                                                                                                                 Migraine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 5325
                                                                                                                                                                                                                               The treatment must be for prophylaxis; AND
                                                                                                                                                                                                                               Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND
                                                                                                                                                                                                                               Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; or
                                                                                                                                                                                                                               Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND
                                                                                                                                                                                                                               Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk.  or
                                                                                                                                                                                                                               Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.
                                                                                                                                                                                                                               Details of the contraindication and/or intolerance(s) must be documented in the patient's medical records when treatment is initiated.
C5338               P5338          CN5338           Selegiline                                                                                                                                                                 Late stage Parkinson disease
                                                                                                                                                                                                                               The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.
C5339               P5339          CN5339           Rasagiline                                                                                                                                                                 Parkinson disease

C5340               P5340          CN5340           Tetrabenazine                                                                                                                                                              Hyperkinetic extrapyramidal disorders                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 5340

C5341               P5341          CN5341           Riluzole                                                                                                                                                                   Amyotrophic lateral sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The condition must be diagnosed by a neurologist; AND
                                                                                                                                                                                                                               Patient must not have had the disease for more than 5 years; AND
                                                                                                                                                                                                                               Patient must have at least 60 percent of predicted forced vital capacity within the 2 months before commencing therapy with this drug; AND
                                                                                                                                                                                                                               Patient must be ambulatory; or
                                                                                                                                                                                                                               Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND
                                                                                                                                                                                                                               Patient must not have undergone a tracheostomy; AND
                                                                                                                                                                                                                               Patient must not have experienced respiratory failure.
                                                                                                                                                                                                                               The date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) must be supplied with the initial authority application.
C5342               P5342          CN5342           Desmopressin                                                                                                                                                               Primary nocturnal enuresis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 5342
                                                                                                                                                                                                                               Patient must be 6 years of age or older;
                                                                                                                                                                                                                               Patient must be refractory to an enuresis alarm.
C5357               P5357          CN5357           Cabergoline                                                                                                                                                                Pathological hyperprolactinaemia
                                                                                                                                                                                                                               Patient must have had radiotherapy for this condition with incomplete resolution.
                                                    Quinagolide

C5359               P5359          CN5359           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Dynamic equinus foot deformity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 5359
                                                                                                                                                                                                                               The condition must be due to spasticity;