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ADEC 246th meeting resolutions, 1-2 June 2006

Australian Drug Evaluation Committee

1 June 2003

Published in the Commonwealth of Australia Gazette, No. GN 25, 28 June 2006

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 246th (2006/3) meeting of the Australian Drug Evaluation Committee (ADEC) (1-2 June 2006) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

RESOLUTION NO 8952

There should be no objection to approval of the submission from Ipsen Pty Limited to register the new chemical entity triptorelin, present as the embonate, as DIPHERELINE powder for injection 3.75mg and 11.25mg for the indication:

for the treatment of locally advanced or metastatic prostate cancer.

RESOLUTION NO 8953

There should be no objection to approval of the submission from CSL Pty Limited to register the new formulation of human normal immunoglobulin as SANDOGLOBULIN NF LIQUID 120 g/L for the indications:

replacement therapy in:

  • primary immune deficiency syndromes such as:
    • congenital agammaglobulinaemia and hypogammaglobulinaemia
    • common variable immunodeficiency
    • severe combined immunodeficiency
    • Wiskott Aldrich syndrome.
  • myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
  • children with congenital acquired immunodeficiency syndrome and recurrent infections.

immunomodulatory therapy in:

  • idiopathic thrombocytopenic purpura in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.
  • Guillain-Barre Syndrome.
  • Kawasaki disease.
  • allogenic bone marrow transplantation.

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RESOLUTION NO 8956

  1. There should be no objection to the approval of the submission from Roche Products Pty Limited to register the new strength and new dose form of saquinavir mesylate as INVIRASE film coated tablets 500mg for the indications:
    • for the treatment of HIV/AIDS in adults and children 12 years of age and older. Clinical studies indicate that saquinavir should only be used in combination with ritonavir and other anti-retroviral therapies (SEE CLINICAL TRIALS).
    • This indication is based on changes in surrogate markers. At present there are no results from controlled clinical trials evaluating the effect of regimens containing saquinavir tablets on HIV disease progression or survival (SEE CLINICAL TRIALS).
  2. There should be no objection to the approval of the application to amend the dosage regimen to ensure that invirase film-coated tablets 500 mg are co-administered with ritonavir.

RESOLUTION NO 8957

There should be no objection to the approval of the submission from Roche Products Pty Limited to register the new strength and formulation of ibandronic acid as BONDRONAT tablets 50mg for the indication:

the treatment of metastatic bone disease in patients with breast cancer.

RESOLUTION NO 8959

There should be no objection to approval of the submission from Actelion Pharmaceuticals Australia Pty Limited to register TRACLEER tablets containing bosentan 62.5mg and 125mg for the new indication:

for familial pulmonary hypertension.

RESOLUTION NO 8960

There should be no objection to the approval of the submission from Solvay Pharmaceuticals Pty Limited to register INFLUVAC containing 15 µg haemagglutinin in 0. 5mL of each of 3 influenza strains (A/H3N1, A/H1N1, B) for use in children from 6 months of age.

RESOLUTION NO 8961

There should be no objection to the approval of the submission from Abbott Australasia Pty Ltd to register HUMIRA solution for injection containing adalimumab 40mg/0.8mL for the new indication:

Humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

RESOLUTION NO 8963

  1. There should be no objection to approval of the submission by AstraZeneca Pty Ltd to register the new dosage regimen known as "Symbicort Maintenance and Reliever Therapy" for SYMBICORT 100/6 turbuhaler and SYMBICORT 200/6 turbuhaler containing budesonide 100µg and 200µg with eformoterol 6µg respectively per actuation.
  2. Approval for the new dosage regimen should be restricted to use in adults and adolescents.

RESOLUTION NO 8964

There should be no objection to approval of the submission from Ipsen Pty Ltd to register NUTROPIN AQ solution for injection containing somatropin 10mg/2mL for the indication:

The long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion, long-term treatment of growth failure associated with Turner syndrome, treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation, treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak GH concentrations of less than 2.5 ng/mL.

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RESOLUTION NO 8966

There should be no objection to approval of the submission from Sanofi-Synthelabo Australia Pty Ltd to register STILNOX CR, STILNOXIUM CR and DORMIZOL CR modified release tablets containing zolpidem tartrate 6.25mg and 12.5mg for the indication:

the short term treatment of insomnia in adults.

RESOLUTION NO 8967

Further to Resolution 8642, there should be no objection to approval of the submission by Organon (Australia) Pty Ltd to register the new dose form NUVARING vaginal ring containing etonogestrel 11.7mg and ethinylestradiol 2.7mg for the indication:

for use for contraception.

RESOLUTION NO 8968

There should be no objection to the approval of the submission from Arrow Pharmaceuticals Limited to register GYNAZOLE-1 cream containing butaconazole nitrate 2% for the indication:

for the single dose local treatment of candidal vulvovaginitis.

RESOLUTION NO 8969

There should be no objection to the approval of the submission from GlaxoSmithKline Australia Pty Ltd to register RELENZA ROTADISK powder for inhalation containing zanamivir 5mg for the new indication:

Vaccination remains the primary method of preventing and controlling influenza. RELENZA is indicated for prophylaxis of influenza A and B in adults and children (= 5 years) to reduce transmission among individuals in households with an infected person. RELENZA is indicated for prophylaxis of influenza A and B during community outbreaks only in circumstances where such prophylaxis is justified (such as when vaccine that antigenically matches circulating influenza is not available or there is a pandemic). It is not recommended for routine prophylaxis against influenza infection.

RESOLUTION NO 8970

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register METHADONE SYRUP oral liquid containing methadone 10mg/mL for the new indication:

for the treatment of severe pain.

RESOLUTION NO 8971

There should be no objection to the approval of the submission from Merck Sharp & Dohme (Australia) Pty Limited to register GARDASIL suspension for injection containing the new chemical entity quadrivalent Human Papillomavirus [Types 6, 11, 16,18] recombinant vaccine in which each 0.5 mL dose contains approximately 20 µg HPV 6 L1 protein, 40 µg HPV 11 L1 protein, 40 µg HPV 16 L1 protein, and 20 µg HPV 18 L1 protein, for the indications:

GARDASIL is indicated in females aged 9 to 26 years* for the prevention of cervical, vulvar and vaginal cancer, precancerous or dysplastic lesions, genital warts and infection caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18 (which are included in the vaccine).

GARDASIL is indicated in males aged 9 to 15 years for the prevention of infection caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18 (which are included in the vaccine).

*Immunogenicity studies have been conducted to link efficacy in females aged 16 to 26 years to the younger populations.

28 June 2006