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ADEC 262nd meeting resolutions, 6 February 2009

Australian Drug Evaluation Committee

6 February 2009

Published in the Commonwealth of Australia Gazette, No. GN 11, 25 March 2009

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 262nd (2009/1) meeting of the Australian Drug Evaluation Committee (ADEC) (6 February 2009) 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 9254

There should be no objection to approval of the submission from Sanofi Pasteur Pty Ltd to register EMERFLU suspension for injection, containing the new biological entity influenza virus haemagglutinin [H5N1] containing inactivated split virus (monovalent) 30µg /0.5 mL for the indication:

For the prevention of influenza caused by a pandemic strain of influenza virus. Pandemic influenza vaccine should be used in accordance with official guidance.

RESOLUTION 9255

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register DORIBAX powder for injection containing the new chemical entity doripenem monohydrate 500 mg for the indication:

For treatment of following infections in adults caused by bacteria sensitive to doripenem, which are proven or suspected to be resistant to other antibiotics or in patients who are unable to tolerate other antibiotics.

  1. Complicated intra-abdominal infections
  2. Nosocomial pneumonia, including ventilator-associated pneumonia
  3. Complicated urinary tract infections, including pyelonephritis and cases with concurrent bacteremia.

Doripenem is not efficacious against methicillin resistant Staphylococcus aureus (MRSA).

RESOLUTION 9256

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register SYNFLORIX injection suspension containing the new biological entity pneumococcal polysaccharide and Haemophilus influenzae Protein D conjugate vaccine, 10 valent adsorbed, in which each 0.5 mL dose contains 1 µg of pneumococcal polysaccharide serotypes 1, 5, 6B, 7F, 9V, 14 & 23 and 3 µg of pneumococcal polysaccharide serotypes 4, 18C, 19F & 23F for the indication:

Active immunisation of infants and children from the age of 6 weeks up to 2 years against disease caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (including invasive disease, pneumonia, and acute otitis media).

RESOLUTION 9257

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register GARDASIL Injection suspension containing Human Papillomavirus (Types 6, 11, 16, 18) for the new indication:

GARDASIL is indicated in females aged 27 to 45 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).

RESOLUTION 9258

There should be no objection to approval of the submission from Phebra Pty Ltd to register PHENASEN Injection solution containing the new chemical entity arsenic trioxide 10 mg / 10 mL for the indication:

For the induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PLL/RAR-alpha gene expression.

RESOLUTION 9259

There should be no objection to approval of the submission from Alphapharm Pty Ltd to register the new strength DIABEX XR 750 tablets containing metformin hydrochloride 750 mg for the indication:

Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Diabex XR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

RESOLUTION 9260

There should be no objection to approval of the submission from Sanofi-Aventis Australia Pty Ltd to register the new strength of ACTONEL ONCE-A-MONTH tablets containing risedronate sodium 150 mg for the indication:

  • Treatment of osteoporosis
  • Treatment of glucocorticoid induced osteoporosis (GIO)
  • Preservation of bone mineral density in patients on long term corticosteroid therapy

RESOLUTION 9262

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register the fixed combination JANUMET tablets containing sitagliptin (as phosphate monohydrate) and metformin hydrochloride 50 mg/500 mg, 50 mg/850 mg & 50 mg/1000 mg for the new indication (dual therapy as second line therapy):

As an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus inadequately controlled on metformin alone or in patients already treated with the combination of sitagliptin and metformin.

RESOLUTION 9263

There should be no objection to approval of the submission for a new biological entity from Sanofi Pasteur Pty Ltd to register INTANZA 9 µg injection containing Influenza virus haemagglutinin (comprising of 9 µg haemagglutinin/strain/0.1 mL) and INTANZA 15 µg injection suspension containing Influenza virus haemagglutinin (comprising of 15 µg haemagglutinin/strain/0.1 mL) for the indications:

INTANZA 9 µg
Prophylaxis of influenza in adults from 18 to 59 years of age. Use in Australia should be based on the NHMRC recommendations for influenza vaccination published in the current Immunisation Handbook.

INTANZA 15 µg
Prophylaxis of influenza in individuals 60 years and over. Use in Australia should be based on the NHMRC recommendations for influenza vaccination published in the current Immunisation Handbook.

RESOLUTION 9264

There should be no objection to approval of the submission from Nycomed Pty Ltd to register SOMAC / PANTOLOC tablet containing pantoprazole 20 mg and 40 mg for use in children from 5 years to 17 years of age for the indications:

For use in children aged from 5 years for treatment of gastro-oesophageal reflux disease (GORD)

  • Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD
  • Reflux oesophagitis

24 February 2009