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Scheduling delegate's final decisions: ACCS/ACMS, February 2013

Scheduling medicines and poisons

8 February 2013

Book pagination

Part B - Final decisions on matters not referred to an expert advisory committee

4. New chemical entities - medicines for human therapeutic use

4.1 Alogliptin

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule alogliptin, a new chemical entity for a human therapeutic medicine.

Alogltiptin is an inhibitor of dipeptidylpeptidase-4 (anti-diabetic DPP-4 inhibitor) and is proposed for use in the treatment of Type 2 diabetes mellitus.

Scheduling status

Alogliptin is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Alogliptin is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The new drug application (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include alogliptin in Schedule 4, with an implementation date of 1 May 2013.

The delegate decided that the relevant matter under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) risks and benefits of the use of a substance.

The delegate's reason for the final decision is that alogliptin is a new chemical entity with no clinical or marketing experience in Australia.

Schedule 4 - New Entry

ALOGLIPTIN.

4.2 Canagliflozin

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule canagliflozin, a new chemical entity for a human therapeutic medicine.

Canagliflozin is an inhibitor of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter causes blood glucose to be eliminated through the urine.

Canagliflozin is proposed for use in the treatment of type 2 diabetes mellitus.

Scheduling status

Canagliflozin is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Canagliflozin is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The new drug application (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include canagliflozin in Schedule 4, with an implementation date of 1 May 2013.

The delegate decided that the relevant matter under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) risks and benefits of the use of a substance.

The delegate's reason for the final decision is that canagliflozin is a new chemical entity with no clinical or marketing experience in Australia.

Schedule 4 - New Entry

CANAGLIFLOZIN.

4.3 Crofelemer

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule crofelemer, a new chemical entity for a human therapeutic medicine.

Crofelemer is a proanthocyanidin from the bark latex of the tree Croton lechleri that acts locally on the intestinal lumen to normalise flow of chloride ions and water into the gastrointestinal tract.

Crofelemer is indicated for the control and symptomatic relief of diarrhoea in patients with HIV/AIDS.

Scheduling status

Crofelemer is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Crofelemer is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The new drug application (not publicly available).
  • The TGA evaluation report (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that:

  • Limited safety information suggests low toxicity. Very little crofelemer is absorbed. Its purported mechanism in ameliorating the symptoms in HIV-associated diarrhoea is inhibition of chloride ion secretion. The inhibition blocks chloride secretion and accompanying high volume water loss in secretory diarrhoea, normalising the flow of chloride ions and water in the gastrointestinal tract.
  • The recommended dose of crofelemer is one 125 mg tablet taken orally two times a day, with or without food. No dosage adjustment is required for renal or hepatic disease or for patients on dialysis.
  • The potential for abuse is low.
  • There are currently no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include crofelemer in Schedule 4, with an implementation date of 1 May 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and extent of use; and (f) any other matters considered necessary to protect public health.

The delegate's reasons for the final decision comprise of the following.

  • It is a new chemical entity with no clinical or marketing experience in Australia.
  • It is indicated for a specific population group taking multiple medications, but few drug interaction studies have been performed.
  • No active control efficacy and safety studies were submitted and there is minimal pharmacokinetics.

Schedule 4 - New Entry

CROFELEMER.

4.4 Dimethyl fumarate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule dimethyl fumarate, a new chemical entity for a human therapeutic medicine.

Dimethyl fumarate is indicated for patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Scheduling status

Dimethyl fumarate is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Dimethyl fumarate is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The new drug application (not publicly available).
  • The TGA evaluation report (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that there are currently no issues of concern that require additional control other than by inclusion in Schedule 4. The pregnancy category is yet to be finalised, but it is not a pregnancy category D or X agent.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include dimethyl fumarate in Schedule 4, with an implementation date of 1 May 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and extent of use; (c) toxicity and (f) dosage, formulation, labelling, packaging and presentation.

The delegate's reasons for the final decision comprise of the following.

  • It is a new chemical entity with no clinical or marketing experience in Australia.
  • It is an immunomodifying agent for use in the treatment of Multiple Sclerosis.
  • As an immunomodifying agent, the product has considerable toxicity.
  • It is an oral agent requiring instructions to healthcare professionals and consumers.

Schedule 4 - New Entry

DIMETHYL FUMARATE.

4.5 Ivacaftor

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule ivacaftor, a new chemical entity for a human therapeutic medicine.

Ivacaftor is a respiratory agent. It potentiates the cystic fibrosis transmembrane conductance protein (CFTR), specifically G551D-CFTR, resulting in increased chloride transport on the surface of epithelial cells in multiple organs.

Ivacaftor is proposed for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have a G551D mutation in the CFTR gene.

Scheduling status

Ivacaftor is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Ivacaftor is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The new drug application (not publicly available).
  • The TGA evaluation report (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include ivacaftor in Schedule 4, with an implementation date of 1 May 2013.

The delegate decided that the relevant matter under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) risks and benefits of the use of a substance.

The delegate's reason for the final decision is that ivacaftor is a new chemical entity with no clinical or marketing experience in Australia.

Schedule 4 - New Entry

IVACAFTOR.

4.6 Micafungin

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule micafungin, a new chemical entity for a human therapeutic medicine.

Micafungin is an echinocandin class of antifungal agents. It is indicated for the treatment of invasive candidiasis, oesophageal candidiasis for whom IV therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia for 10 or more days.

Scheduling status

Micafungin is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Micafungin is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The TGA evaluation reports (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include micafungin in Schedule 4, with an implementation date of 1 May 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and extent of use; (c) toxicity; and (d) dosage, formulation, packaging and presentation.

The delegate's reasons for the final decision comprise of the following.

  • It is a new chemical entity with no clinical or marketing experience in Australia.
  • Other substances of the same class are included in Schedule 4.
  • It is to be used in a patient population with very high morbidity and mortality.
  • Intervention by a medical professional is required for diagnosis, management and monitoring of the conditions to be treated.
  • Identified risks include allergic reactions, haemolytic reactions, Steven-Johnson's syndrome and damage to liver and kidneys.

Schedule 4 - New Entry

MICAFUNGIN.

4.7 Olodaterol

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule olodaterol, a new chemical entity for a human therapeutic medicine.

Olodaterol is a long-acting beta2-agonist and is proposed for use in the treatment of chronic obstructive pulmonary disease (COPD).

Scheduling status

Olodaterol is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Olodaterol is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include olodaterol in Schedule 4, with an implementation date of 1 May 2013.

The delegate agreed that the relevant matter under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) risks and benefits of the use of a substance.

The delegate's reason for the final decision is that olodaterol is a new chemical entity with no clinical or marketing experience in Australia.

Schedule 4 - New Entry

OLODATEROL.

4.8 Pasireotide diaspartate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule pasireotide diaspartate, a new chemical entity for a human therapeutic medicine.

Pasireotide diaspartate is proposed for the treatment of patients with Cushing's disease for whom medical therapy is appropriate. It is a somatostatin analogue that binds to 4 of the 5 human somatostatin (hsst) receptors, especially hsst-5 which is expressed at high levels in corticotropin (ACTH)-producing adenomas. The resulting inhibition of ACTH secretion is used in the treatment of Cushing's disease, particularly when surgery is not an option or has failed. It is given as the diaspartate, but doses are expressed in terms of the base; 125 micrograms of pasireotide diaspartate is equivalent to about 100 micrograms of pasireotide.

Scheduling status

Pasireotide and pasireotide diaspartate are not specifically scheduled and are not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Pasireotide and pasireotide diaspartate are not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The new drug application (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include pasireotide and pasireotide diaspartate in Schedule 4, with an implementation date of 1 May 2013.

The delegate agreed that the relevant matter under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) risks and benefits of the use of a substance.

The delegate's reason for the final decision is that pasireotide and pasireotide diaspartate are new chemical entities with no clinical or marketing experience in Australia.

Schedule 4 - New Entries

PASIREOTIDE.

PASIREOTIDE DIASPARTATE.

4.9 Retapamulin

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule retapamulin, a new chemical entity for a human therapeutic medicine.

Retapamulin is an antibiotic, indicated for the topical treatment of the following bacterial skin and skin structure infections (SSSI):

  • primary impetigo;
  • secondary infected traumatic lesions e.g. small lacerations, abrasions, sutured wounds; and
  • secondary infected dermatoses including infected psoriasis, infected atopic dermatitis and infected contact dermatitis.
Scheduling status

Retapamulin is not specifically scheduled in Australia, but is captured by the Schedule 4 class entry for antibiotic substances.

Retapamulin is not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • The TGA evaluation report (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
  • Long-standing scheduling policy that antibiotics are specifically scheduled.

The delegate noted that there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include retapamulin in Schedule 4, with an implementation date of 1 May 2013.

The delegate agreed that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits and (b) purpose and extent of use.

The delegate's reasons for the final decision comprise of the following:

  • It is a new chemical entity with no clinical or marketing experience in Australia.
  • It is to be prescribed by medical practitioners to treat specific bacterial skin and skin structure infections.

Schedule 4 - New Entry

RETAPAMULIN.

4.10 Vilanterol trifenatate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule vilanterol trifenatate, a new chemical entity for a human therapeutic medicine.

Vilanterol trifenatate is a long-acting beta2 agonist and is proposed for use in the treatment of asthma in adults and adolescents aged 12 years and above.

Scheduling status

Vilanterol and vilanterol trifenate are not specifically scheduled and are not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Vilanterol and vilanterol trifenatate are not classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include vilanterol and vilanterol trifenatate in Schedule 4, with an implementation date of 1 May 2013.

The delegate agreed that the relevant matter under subsection 52E(1) of the Therapeutic Goods Act 1989 is (a) risks and benefits of the use of a substance.

The delegate's reason for the final decision is that vilanterol and vilanterol trifenatate are new chemical entities with no clinical or marketing experience in Australia.

Schedule 4 - New Entries

VILANTEROL.

VILANTEROL TRIFENATATE.

5. New chemical entities - poisons

5.1 Cyantraniliprole

Scheduling proposal

The chemical scheduling delegate (delegate) considered a proposal from the Office of Chemical Safety (OCS) to include cyantraniliprole, a new insecticide, in Schedule 5 with no cut-off.

The OCS evaluated data that was provided in support of an application for approval of the new insecticide. The applicant was provided with a copy of the OCS evaluation report and supports the proposed Schedule 5 entry.

The delegate decided to make a delegate-only decision. The Advisory Committee on Chemicals Scheduling (ACCS) was not consulted.

Scheduling status

Cyantraniliprole is not specifically scheduled. Other similar substances, such as chlorantraniliprole and flubendiamide are listed in Appendix B and in Schedule 5 respectively.

Scheduling consideration

The delegate considered the following in regards to this application:

  • The OCS evaluation report (not publicly available).
  • The applicant's support for inclusion in Schedule 5.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include cyantraniliprole in Schedule 5, with an implementation date of 1 May 2013.

The delegate decided that the relevant matter under section 52E (1) of the Therapeutic Goods Act 1989 is (c) toxicity.

The delegate's reasons for the final decision comprise of the following.

  • The toxicological profile of cyantraniliprole is well characterised. Based on the OCS evaluation report, this profile is consistent with either listing in Schedule 5 or exemption from scheduling.
  • The primary reason for considering Schedule 5 to be more appropriate is the slight eye irritancy observed with technical cyantraniliprole, along with the skin and eye irritancy observed with the proposed products (possibly aggravated by other formulation constituents).
  • The Schedule 5 listing is supported by the applicant.

Schedule 5 - New Entry

CYANTRANILIPROLE.

5.2 Tildipirosin

Scheduling proposal

The delegate considered a proposal from the Office of Chemical Safety (OCS) to include tildipirosin, a new chemical entity, in Schedule 4.

The OCS evaluated data that was provided in support of an application for approval of tildipirosin, a new chemical entity for a veterinary medicine. The applicant was provided with a copy of the OCS evaluation report and supports the Schedule 4 entry.

Scheduling status

Tildipirosin is not specifically scheduled.

Scheduling consideration

The delegate considered the following in regards to this application.

  • The OCS evaluation report (not publicly available).
  • The applicant's support for inclusion in Schedule 4.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate decided to make a delegate-only decision. The Advisory Committee on Chemicals Scheduling (ACCS) was not consulted.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include tildipirosin in Schedule 4, with an implementation date of 1 May 2013.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (b) purpose and extent of use; (c) toxicity, and (f) any other matters considered necessary to protect public health.

The delegate's reasons for the final decision comprise of the following:

  • Tildipirosin is a semisynthetic derivative of the macrolide antibiotic tylosin, intended for administration by a veterinarian for the control of respiratory infections.
  • The toxicity of tildipirosin is consistent with that of an antibiotic substance related to tylosin, and requires the professional control of a veterinarian to minimise toxicity in the target species.
  • There are no toxicological issues that would warrant control via any other Schedule. While the OCS report suggests that tildipirosin is inactivated by metabolism and gut actions and is unlikely to represent a significant risk for disseminating microbial resistance, this is not a scheduling issue when Schedule 4 controls put responsibility on the prescribing veterinarian for managing microbial resistance issues.

Schedule 4 - New Entry

TILDIPIROSIN.

6. Editorials and errata

6.1 Eformoterol fumarate dihydrate

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) to schedule eformoterol fumarate dihydrate in relation to a new fixed dose combination product of eformoterol fumarate dihydrate and mometasone.

The eformoterol fumarate dihydrate and mometasone combination product is proposed for use in maintenance treatment of asthma.

The delegate has made a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Eformoterol fumarate dihydrate is not specifically scheduled, but is captured by the Schedule 4 entry for formoterol. Formoterol is classified as a prescription medicine in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application.

  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
  • Current scheduling policy for AANs (Australian Approved Names) to be included in the SUSMP, in line with:
    • paragraph 2 under Reading the Schedules in the Introduction to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP); and
    • 'approved name' in Part 1, Interpretation of the SUSMP.
  • Eformoterol (et al) is the AAN and formoterol (et al) is the INN (International Nonproprietary Name).
  • Scheduling history
    • In February 1997, the then National Drugs and Poisons Schedule Committee (NDPSC) included the new chemical entity 'eformoterol' in Schedule 4.
    • In November 1999, the NDPSC amended the Schedule 4 entry to read 'eformoterol (formoterol)' to achieve partial harmonisation with New Zealand who had classified 'formoterol' as a prescription medicine.
    • In October 2006, the NDPSC amended the Schedule 4 entry to read 'formoterol' in line with the then scheduling policy of including INNs in the Poisons Standard and to achieve full harmonisation with New Zealand.
  • Currently, there are 10 products on the ARTG containing 'eformoterol' (et al), but no products containing 'formoterol' (et al).
Delegate's final decision

The delegate has decided that eformoterol fumarate dihydrate is appropriately captured by the Schedule 4 entry for formoterol.

However, in line with current scheduling policy that AANs (Australian Approved Names) are to be included in the Standard for the Uniform Scheduling of Medicines and Poisons, the delegate has made a final decision to editorially amend the current Schedule 4 entry for formoterol to read eformoterol, with an implementation date of 1 May 2013.

Schedule 4 - Amendment

FORMOTEROL - Amend entry to read:

EFORMOTEROL.

6.2 Thiamazole

Scheduling proposal

The chemicals scheduling delegate (the delegate) has initiated an editorial amendment to the thiamazone entry in the Index to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Scheduling consideration
  • In August 2012, the delegate considered a proposal to include carbimazole in Schedule 4 for the management of feline hyperthyroidism.
  • The delegate noted that the data submitted in the application for carbimazole also consisted of methimazole (also known as thiamazole), which carbimazole is rapidly and completely metabolized to.
  • The delegate noted that thiamazole was previously considered by the delegate and found that the cross-reference entry for thiamazone in the Index of SUSMP No. 3 was incorrectly spelt and should read thiamazole.
Delegate's final decision

The delegate has made a final decision to editorially amend the thiamazone cross-reference entry in the Index of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) to read thiamazole, with the amended entry to be included in the next consolidation of the SUSMP, i.e. SUSMP No.4.

SUSMP Index - Amendment for SUSMP No.4 Consolidation

THIAMAZONE - Amend entry to read:

THIAMAZOLE
See METHIMAZOLE

6.3 Appendix L

Scheduling proposal

The medicines scheduling delegate (the delegate) has initiated an editorial amendment to Appendix L of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Delegate's consideration

The delegate noted that:

  • warning statement '77' [WARNING - May cause birth defects] is incorrectly listed in Appendix L:
    • for acitretin, adapalene, bosentan, etretinate, isotretinoin, lenalidomide, thalidomide and tretinoin when 'for oral use'; and
    • for ambrisentan, bosentan, leflunomide and sitaxentan,
  • the correct warning statement is '7' [WARNING - Causes birth defects];
  • the correct warning statement '7' was listed against these substances in Appendix L in the previous edition of the Standard for the Uniform Scheduling of Medicines and Poisons, i.e. SUSMP2;
  • Appendix L appears to have been corrupted during the consolidation of SUSMP3.
Delegate's final decision

The delegate has made a final decision to editorially amend the Standard for the Uniform Scheduling of Medicines and Poisons to replace warning statement '77' with warning statement '7' in Appendix L:

  • for acitretin, adapalene, bosentan, etretinate, isotretinoin, lenalidomide, thalidomide and tretinoin when 'for oral use'; and
  • for ambrisentan, bosentan, leflunomide and sitaxentan.

The delegate has decided that the implementation date for this decision will be 1 May 2013.

Appendix L, Part 2 - Amendments
Column 1
Substance
Column 2
Warning statement

Acitretin - Amend entry to read:

Acitretin:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77

Adapalene - Amend entry to read:

Adapalene:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Ambrisentan - Amend entry to read:
Ambrisentan. 7, 62 and 76

Bexarotene - Amend entry to read:

Bexarotene:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Bosentan - Amend entry to read:
Bosentan. 7, 62 and 76

Etretinate - Amend entry to read:

Etretinate:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77

Isotretinoin - Amend entry to read:

Isotretinoin:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Leflunomide - Amend entry to read:
Leflunomide. 7, 62 and 87

Lenalidomide - Amend entry to read:

Lenalidomide:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Sitaxentan - Amend entry to read:
Sitaxentan. 7, 62 and 76

Thalidomide - Amend entry to read:

Thalidomide:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77

Tretinoin - Amend entry to read:

Tretinoin:

(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77

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