Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p91
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 91/191)
Character Range: 10541356–10554556

previously untreated; AND
                                                                                                                                                                                                                               The condition must be symptomatic; AND
                                                                                                                                                                                                                               The treatment must be for induction treatment purposes only; AND
                                                                                                                                                                                                                               The treatment must be in combination with rituximab or obinutuzumab; AND
                                                                                                                                                                                                                               The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
C7944               P7944          CN7944           Bendamustine                                                                                                                                                               Follicular lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 7944
                                                                                                                                                                                                                               Re-induction treatment
                                                                                                                                                                                                                               The condition must be CD20 positive; AND
                                                                                                                                                                                                                               The condition must be refractory to treatment with rituximab for this condition; AND
                                                                                                                                                                                                                               The condition must be symptomatic; AND
                                                                                                                                                                                                                               The treatment must be for re-induction treatment purposes only; AND
                                                                                                                                                                                                                               The treatment must be in combination with obinutuzumab; AND
                                                                                                                                                                                                                               The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
                                                                                                                                                                                                                               The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
C7970               P7970          CN7970           Budesonide with formoterol                                                                                                                                                 Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7970
                                                                                                                                                                                                                               Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.  or
                                                                                                                                                                                                                               Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy.  or
                                                                                                                                                                                                                               Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.
C7972               P7972          CN7972           Bendamustine                                                                                                                                                               Previously untreated stage III or IV mantle cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 7972
                                                                                                                                                                                                                               Induction treatment
                                                                                                                                                                                                                               The condition must be CD20 positive; AND
                                                                                                                                                                                                                               The treatment must be in combination with rituximab; AND
                                                                                                                                                                                                                               The condition must be previously untreated; AND
                                                                                                                                                                                                                               The condition must be symptomatic; AND
                                                                                                                                                                                                                               The treatment must be for induction treatment purposes only; AND
                                                                                                                                                                                                                               Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND
                                                                                                                                                                                                                               Patient must not be eligible for stem cell transplantation.
C7979               P7979          CN7979           Budesonide with formoterol                                                                                                                                                 Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7979
                                                                                                                                                                                                                               Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
C8161               P8161          CN8161           Octreotide                                                                                                                                                                 Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 8161
                                                                                                                                                                                                                               The condition must be controlled with octreotide immediate release injections; AND
                                                                                                                                                                                                                               The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
                                                                                                                                                                                                                               The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
                                                                                                                                                                                                                               The treatment must not