National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 4) (Cth)

Case

PB 38 of 2021

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 4)

National Health Act 1953

________________________________________________________________________

I, THEA CONNOLLY, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated    28 April               2021

THEA CONNOLLY

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

  1. Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 4).

(2)This Instrument may also be cited as PB 38 of 2021.

  1. Commencement

This Instrument commences on 1 May 2021.

  1. Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1           Amendments

  1. Schedule 1, Part 1, entry for Aciclovir

(a)omit:

Eye ointment 30 mg per g, 4.5 g (Acivision) Application to the eye AciVision DZ MP NP C5965 1 0 1
AO C5964 1 0 1

(b)insert as first entry:

Eye ointment 30 mg per g, 4.5 g Application to the eye ViruPOS AE MP NP C5965 1 0 1
AO C5964 1 0 1

  1. Schedule 1, Part 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a NOUMED AMLODIPINE VO MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Bimprozt TY AO MP 1 5 1

  1. Schedule 1, Part 1, after entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

insert:

Cannabidiol Oral liquid 100 mg per mL,
100 mL 		Oral Epidyolex EU MP C11681 1 5 1

  1. Schedule 1, Part 1, entry for Cyclophosphamide in the form Tablet 50 mg (anhydrous)

omit from the column headed “Responsible Person”: ZX             substitute: GH

  1. Schedule 1, Part 1, entry for Doxycycline in the form Tablet 50 mg (as hyclate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APX-Doxycycline TX MP NP C4475 C4529 C4539 25 5 25

  1. Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 7; Number of Repeats: 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APX-Doxycycline TX PDP 7 0 7

  1. Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 7; Number of Repeats: 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APX-Doxycycline TX MP NP 7 1 7

  1. Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 21; Number of Repeats: 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APX-Doxycycline TX MP NP P4485 21 0 7
MP NP P4485 21 0 21

  1. Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 28; Number of Repeats: 0]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APX-Doxycycline TX MP NP P4514 28 0 7

  1. Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [Maximum Quantity: 28; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APX-Doxycycline TX MP P6200 28 5 7

  1. Schedule 1, Part 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

omit:

a Andepra EL MP NP C5650 28 0 28

  1. Schedule 1, Part 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

omit:

a Andepra EL MP NP C5650 28 5 28

  1. Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

omit:

Epirubicin ACT JU MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

omit:

Epirubicin ACT JU MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, Part 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and Tablet 150 mg (as hydrochloride)

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Erlotinib APOTEX TX MP C4473 C4600 C7446 30 3 30

(b)insert in the column headed “Schedule Equivalent” for the brand “Erlotinib Sandoz”: a

  1. Schedule 1, Part 1, entry for Levetiracetam in the form Oral solution 100 mg per mL, 300 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Levetiracetam GH GQ MP NP C11077 1 5 1

  1. Schedule 1, Part 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Lurasidone Sandoz SZ MP NP C4246 30 5 30

  1. Schedule 1, Part 1, entry for Mesalazine in the form Tablet 800 mg (enteric coated)

omit from the column headed “Maximum Quantity”: 180             substitute: 90

  1. Schedule 1, Part 1, after entry for Mesalazine in the form Tablet 1.2 g (prolonged release)

insert:

Tablet 1.6 g (enteric coated) Oral Asacol EU MP NP C9444 120 4 60

  1. Schedule 1, Part 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

b NOUMED METOPROLOL VO MP NP 100 5 100

  1. Schedule 1, Part 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

b NOUMED METOPROLOL VO MP NP 60 5 60

  1. Schedule 1, Part 1, entry for Norethisterone with ethinylestradiol in the form Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets

insert in the column headed “Schedule Equivalent” (all instances): a

  1. Schedule 1, Part 1, entry for Norethisterone with ethinylestradiol

omit:

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP Oral Pirmella 1/35 DZ MP NP 4 2 3

  1. Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

omit:

NOUMED PERINDOPRIL VO MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

omit:

NOUMED PERINDOPRIL VO MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

omit:

NOUMED PERINDOPRIL VO MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Rasagiline

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Rasazil GQ MP NP C5339 30 5 30

  1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 10 mg

(a)omit:

a Ransim RA MP NP 30 5 30

(b)omit:

a Ransim RA MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 80 mg

(a)omit:

a Ransim RA MP NP 30 5 30

(b)omit:

a Ransim RA MP P7598 30 11 30

  1. Schedule 1, Part 1, entry for Sotalol in each of the forms: Tablet containing sotalol hydrochloride 80 mg; and Tablet containing sotalol hydrochloride 160 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a APX-Sotalol TY MP NP C5664 60 5 60

  1. Schedule 1, Part 1, entry for Stiripentol in each of the forms: Capsule 250 mg; Capsule 500 mg; Powder for oral suspension 250 mg; and Powder for oral suspension 500 mg

omit from the column headed “Circumstances”: C10632             substitute: C11642

  1. Schedule 1, Part 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

substitute:

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg Oral CIPLA TENOFOVIR + EMTRICITABINE 300/200 LR MP NP C11143 30 2 30
Tenofovir/Emtricitabine 300/200 APOTEX TX MP NP C11143 30 2 30
CIPLA TENOFOVIR + EMTRICITABINE 300/200 LR MP NP C6985 C6986 60 5 30 C(100)
Tenofovir/Emtricitabine 300/200 APOTEX TX MP NP C6985 C6986 60 5 30 C(100)

  1. Schedule 1, Part 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg

omit from the column headed “Circumstances”: C10273

  1. Schedule 1, Part 2, omit entry for Codeine

  1. Schedule 1, Part 2, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

omit:

a Cyprocur 50 AS MP P5532 20
CN5532 		5
CN5532 		20
MP 100 5 50

  1. Schedule 1, Part 2, entry for Cyproterone

omit:

Tablet containing cyproterone acetate 100 mg Oral a Cyprocur 100 AS MP 50 5 50

  1. Schedule 1, Part 2, omit entry for Paracetamol

  1. Schedule 3

omit:

ZX Zenex Pharmaceuticals Pty Ltd 51 603 281 509

  1. Schedule 4, Part 1, entry for Bortezomib

substitute:

Bortezomib C7938 Multiple myeloma
Retreatment of Progressive disease - Initial PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease; AND
Patient must have previously been treated with PBS-subsidised bortezomib; AND
Patient must have experienced at least a partial response to the most recent course of PBS-subsidised bortezomib therapy; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Details of the basis of the current diagnosis of progressive disease and nomination of which disease activity parameters that will be used to assess response, and diagnostic reports demonstrating the patient has achieved at least a partial response to the most recent course of PBS-subsidised bortezomib, if not previously documented must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) must be documented in the patient's medical records. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7938
C7939 Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7939
C7940 Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have received an initial authority prescription for bortezomib for newly diagnosed symptomatic multiple myeloma and be ineligible for high dose chemotherapy; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
Patient must not have achieved a best confirmed response to bortezomib at the time of prescribing; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
Continuing PBS-subsidised supply requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months. 		Compliance with Authority Required procedures - Streamlined Authority Code 7940
C7941 Symptomatic multiple myeloma
Continuing PBS-subsidised treatment
Patient must have previously received PBS-subsidised treatment with this drug for newly diagnosed symptomatic multiple myeloma; AND
Patient must have severe acute renal failure; AND
Patient must have demonstrated at least a partial response at the completion of cycle 4; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 5 cycles of treatment with bortezomib under this restriction.
A copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology authority and diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are not being used to monitor disease activity, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Continuing PBS-subsidised supply requires that the gap between the initial PBS-subsidised treatment with this drug for this condition and this continuing treatment is no more than 6 months. 		Compliance with Authority Required procedures - Streamlined Authority Code 7941
C7960 Multiple myeloma
Retreatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib in the current treatment course; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7960
C7961 Multiple myeloma
Treatment of Progressive disease - Initial PBS-subsidised treatment
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must not be receiving concomitant PBS-subsidised carfilzomib, thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; details of the basis of the diagnosis of progressive disease or failure to respond; and nomination of which disease activity parameters will be used to assess response must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 7961
C7962 Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 8 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 8 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 10 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition following completion of 8 treatment cycles; AND
Patient must not receive more than 3 cycles of bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 9 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7962
C7974 Multiple myeloma
Treatment of Progressive disease - Continuing PBS-subsidised treatment
The treatment must be as monotherapy; OR
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must have previously received 4 treatment cycles of bortezomib for progressive disease; AND
Patient must have demonstrated at the completion of cycle 4 at least a partial response to bortezomib; AND
Patient must not have received 2 treatment cycles after first achieving a confirmed complete response; AND
Patient must not have a gap of more than 6 months between the initial PBS-subsidised treatment with this drug for this condition and continuing PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Diagnostic reports demonstrating the patient has achieved at least a partial response must be documented in the patient's medical records.
If serum M protein is measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 50% reduction in the level of serum M protein (monoclonal protein).
If urine Bence-Jones protein levels are being used to monitor disease activity, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours.
If serum M protein is unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels.
If serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(a) at least a 50% reduction in bone marrow plasma cells; or
(b) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(c) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. MRI or CT-Scan); or
(d) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L.
Diagnostic reports must be no more than one month old at the time of prescribing.
A response assessment prior to cycle 5 must be documented in the patient's medical records.
Confirmation of complete response requires 2 determinations a minimum of 6 weeks apart. 		Compliance with Authority Required procedures - Streamlined Authority Code 7974
C10338 Symptomatic multiple myeloma
Patient must be newly diagnosed; AND
Patient must be eligible for high dose chemotherapy and autologous stem cell transplantation; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with chemotherapy.
Details of the histological diagnosis of multiple myeloma must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10338
C10426 Symptomatic multiple myeloma
Initial PBS-subsidised treatment
The condition must be newly diagnosed; AND
Patient must have severe acute renal failure; AND
Patient must require dialysis; OR
Patient must be at high risk of requiring dialysis in the opinion of a nephrologist; AND
The treatment must be in combination with a corticosteroid and/or cyclophosphamide; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction.
Details of the histological diagnosis of multiple myeloma, the name of the nephrologist who has reviewed the patient and the date of review, a copy of the current pathology reports reporting Glomerular Filtration Rate from an Approved Pathology Authority, and nomination of the disease activity parameter(s) that will be used to assess response must be documented in the patient's medical records. Disease activity parameters include current diagnostic reports of at least one of the following:
(a) the level of serum monoclonal protein; or
(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or
(c) in oligo-secretory and non-secretory myeloma patients only, the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. Magnetic Resonance Imaging (MRI) or computed tomography (CT) scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be documented in the patient's medical records for all patients.
Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be documented in the patient's medical records.
Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. 		Compliance with Authority Required procedures - Streamlined Authority Code 10426
C10454 Multiple myeloma
Triple combination therapy (bortezomib, lenalidomide and dexamethasone)
The condition must be newly diagnosed; AND
The treatment must be in combination with lenalidomide and dexamethasone; AND
The treatment must not be in combination with PBS-subsidised thalidomide, pomalidomide or carfilzomib; AND
The treatment must not be changing from dual combination therapy with lenalidomide and dexamethasone for symptomatic multiple myeloma to triple therapy with lenalidomide, bortezomib and dexamethasone; AND
Patient must not receive more than 8 cycles of treatment with bortezomib under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10454
C10455 Symptomatic multiple myeloma
Initial PBS-subsidised treatment
The condition must be newly diagnosed; AND
Patient must be ineligible for high dose chemotherapy; AND
Patient must not be receiving concomitant PBS-subsidised thalidomide or its analogues; AND
The treatment must be in combination with a corticosteroid and melphalan or cyclophosphamide; AND
Patient must not receive more than 4 cycles of treatment with bortezomib under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 10455
C11099 Multiple myeloma

  1. Schedule 4, Part 1, after entry for Candesartan with hydrochlorothiazide

insert:

Cannabidiol C11681 Severe myoclonic epilepsy in infancy (Dravet syndrome)
Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND
The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs.
Must be treated by a neurologist if treatment is being initiated; OR
Must be treated by a neurologist if treatment is being continued or re-initiated; OR
Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; OR
Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Leflunomide

insert:

Lenograstim C6502 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours. 		Compliance with Authority Required procedures - Streamlined Authority Code 6502
C6507 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia. 		Compliance with Authority Required procedures - Streamlined Authority Code 6507
C6516 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 6516
C6522 Chemotherapy-induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned. 		Compliance with Authority Required procedures - Streamlined Authority Code 6522
C6523 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours. 		Compliance with Authority Required procedures - Streamlined Authority Code 6523
C6532 Chemotherapy-induced neutropenia
Patient must be receiving first-line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned. 		Compliance with Authority Required procedures - Streamlined Authority Code 6532
C6535 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease. 		Compliance with Authority Required procedures - Streamlined Authority Code 6535
C6634 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 6634
C6644 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 6644
C6653 Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 6653
C6654 Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation. 		Compliance with Authority Required procedures - Streamlined Authority Code 6654
C6657 Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation. 		Compliance with Authority Required procedures - Streamlined Authority Code 6657
C6673 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade). 		Compliance with Authority Required procedures - Streamlined Authority Code 6673
C6682 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 6682
C9226 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in osteosarcoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 9226
C9227 Assisting peripheral blood progenitor cell or bone marrow transplantation
The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation. 		Compliance with Authority Required procedures - Streamlined Authority Code 9227
C9229 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin disease. 		Compliance with Authority Required procedures - Streamlined Authority Code 9229
C9230 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in an infant or child with central nervous system tumours. 		Compliance with Authority Required procedures - Streamlined Authority Code 9230
C9231 Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy. 		Compliance with Authority Required procedures - Streamlined Authority Code 9231
C9263 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours. 		Compliance with Authority Required procedures - Streamlined Authority Code 9263
C9264 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade). 		Compliance with Authority Required procedures - Streamlined Authority Code 9264
C9265 Chemotherapy-induced neutropenia
Patient must be receiving standard dose adjuvant chemotherapy for breast cancer; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned. 		Compliance with Authority Required procedures - Streamlined Authority Code 9265
C9266 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 9266
C9314 Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation. 		Compliance with Authority Required procedures - Streamlined Authority Code 9314
C9324 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia. 		Compliance with Authority Required procedures - Streamlined Authority Code 9324
C9325 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 9325
C9326 Chemotherapy-induced neutropenia
Patient must be receiving first-line chemotherapy for Hodgkin disease; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre); AND
The treatment must be used in a patient for whom there is a clinical justification for wishing to continue chemotherapy with the same drug combination, dosage and treatment schedule; AND
Patient must be anticipated to have a good response to treatment providing chemotherapy can be delivered as planned. 		Compliance with Authority Required procedures - Streamlined Authority Code 9326
C9327 Chemotherapy-induced neutropenia
Patient must be receiving treatment with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma. 		Compliance with Authority Required procedures - Streamlined Authority Code 9327

  1. Schedule 4, Part 1, entry for Obinutuzumab

(a)omit entry for Circumstances Code “C7935” and substitute:

Obinutuzumab C7935 Stage II bulky or Stage III/IV follicular lymphoma
Maintenance therapy
Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the previously untreated grandfather restriction; AND
The condition must be CD20 positive; AND
Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures

(b)omit entry for Circumstances Code “C7950” and substitute:

C7950 Follicular lymphoma
Maintenance therapy
Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; OR
Patient must have previously received PBS subsidised treatment with this drug under the rituximab refractory grandfather restriction; AND
The condition must be CD20 positive; AND
The condition must have been refractory to treatment with rituximab; AND
Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND
The treatment must be maintenance therapy; AND
The treatment must be the sole PBS subsidised treatment for this condition; AND
The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. 		Compliance with Authority Required procedures

(c)omit entry for Circumstances Code “C7959” and substitute:

C7959 Follicular lymphoma
Re-induction treatment
Patient must not have previously received PBS-subsidised obinutuzumab; AND
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 bendamustine; AND
The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.
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.
A patient may only qualify for PBS subsidised initiation treatment once in a lifetime under:
i) the previously untreated induction treatment restriction; or
ii) the rituximab-refractory re-induction restriction; or
iii) the previously untreated grandfather restriction; or
iv) the rituximab-refractory grandfather restriction. 		Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Stiripentol

substitute:

Stiripentol C11642 Severe myoclonic epilepsy in infancy (Dravet syndrome)
Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND
The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs.
Must be treated by a neurologist if treatment is being initiated; OR
Must be treated by a neurologist if treatment is being continued or re-initiated; OR
Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; OR
Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued. 		Compliance with Authority Required procedures - Streamlined Authority Code 11642

  1. Schedule 4, Part 1, entry for Trastuzumab emtansine

omit:

C10273 Early HER2 positive breast cancer
Grandfather adjuvant treatment
Patient must have received non-PBS-subsidised treatment with this drug as adjuvant treatment of early HER2 positive breast cancer prior to 1 April 2020; AND
The treatment must have been prescribed within 12 weeks after surgery prior to commencing treatment with this drug; AND
Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND
Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration using non-PBS-subsidised and PBS-subsidised drug supply obtained under the grandfather restriction and the continuing treatment restrictions combined.
Authority applications for grandfather treatment must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Early Breast Cancer - PBS Supporting Information Form which includes details from the pathology report from an approved pathology authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery and the number of non-PBS-subsidised cycles of treatment received by the patient. 		Compliance with Written Authority Required procedures

  1. Schedule 5, entry for Adalimumab

substitute:

Adalimumab GRP-25058 Injection 40 mg in 0.4 mL pre-filled syringe Injection Humira
Injection 40 mg in 0.8 mL pre-filled syringe Injection Amgevita
Hadlima
Humira
Hyrimoz
Idacio
GRP-25059 Injection 20 mg in 0.2 mL pre-filled syringe Injection Humira
Injection 20 mg in 0.4 mL pre-filled syringe Injection Amgevita
Humira
GRP-25060 Injection 40 mg in 0.4 mL pre-filled pen Injection Humira
Injection 40 mg in 0.8 mL pre-filled pen Injection Amgevita
Hadlima
Humira
Hyrimoz
Idacio

  1. Schedule 5, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [GRP-14639]

insert in alphabetical order in the column headed “Brand”: APX-Doxycycline

  1. Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as hyclate) [GRP-15635]

insert in alphabetical order in the column headed “Brand”: APX-Doxycycline

  1. Schedule 5, omit entry for Norethisterone with ethinylestradiol

  1. Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]

omit from the column headed “Brand”: NOUMED PERINDOPRIL

  1. Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]

omit from the column headed “Brand”: NOUMED PERINDOPRIL

  1. Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]

omit from the column headed “Brand”: NOUMED PERINDOPRIL

  1. Schedule 5, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg [GRP-21638]

insert in alphabetical order in the column headed “Brand”: CIPLA TENOFOVIR + EMTRICITABINE 300/200

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