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ADEC 215th meeting resolutions, 5-6 April 2001

Australian Drug Evaluation Committee

5 April 2001

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 215th (2001/2) meeting of the Australian Drug Evaluation Committee (ADEC) (5-6 April 2001) resolved to advise the Parliamentary Secretary to the Minister for Health and Aged Care and the Secretary, Department of Health and Aged Care 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.

INFANRIX-PENTA Combined diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine
Sterile suspension for intramuscular injection in prefilled syringes - each 0.5 mL dose contains diphtheria toxoid 25 Lf U, tetanus toxoid 10 Lf U, pertussis toxoid 25 µg, filamentous haemagglutinin 25 µg, 69 kDa outer membrane protein 8 µg, hepatitis B surface antigen protein 10 µg, type 1 (Mahoney) poliovirus 40 D-antigen units, type 2 (MEF-1) poliovirus 8 D-antigen units, and type 3 (Saukett) poliovirus 32 D-antigen units
Smithkline Beecham (Australia) Pty Ltd
Indication: For the immunisation of infants from the age of six weeks against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis, and as a booster dose at 18 months of age if boosting with hepatitis B and poliomyelitis, as well as diphtheria, tetanus and pertussis, is required.

INFANRIX-HEXA Combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae Type B (Hib) vaccine
Combination pack containing sterile suspension of DTPa/HBV/IVP for intramuscular injection, 0.5 mL in prefilled syringes plus sterile lyophilised Hib vaccine (10 µg) in vials
Smithkline Beecham (Australia) Pty Ltd
Indication: For use as a booster dose at 18 months of age if boosting with hepatitis B, poliomyelitis, and Haemophilus influenzae type B, as well as diphtheria, tetanus, and pertussis, is required.

DIDANOSINE Videx; Videx EC
Videx, chewable tablets, 200 mg;
Videx EC, modified-release capsules, 125 mg, 200 mg, 250 mg and 400 mg
Bristol-Myers Squibb Australia Pty Ltd
Variation: To revise the approved dosage regimen for Videx chewable tablets, to include a once-daily dosage regimen for patients who are unable to take didanosine twice daily, to register a new strength chewable tablet (200mg), and to approve the new dosage form of modified-release capsules, Videx EC.

ZYVOXA Linezolid
Tablets, 400 mg and 600 mg; granules for oral suspension, 20 mg/mL; sterile solution for intravenous injection, 200 mg/100 mL, 400 mg/200 mL, and 600 mg/300 mL
Pharmacia Australia Pty Limited
Indication: For the treatment of suspected or proven infections due to organisms resistant to multiple classes of antibiotics, including methicillin resistant Staphylococcus species and vancomycin resistant Enterococcus species.

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KALETRA Lopinavir/ritonavir
Soft capsules, lopinavir 133.3 mg/ritonavir 33.3 mg; oral solution, lopinavir 400 mg/ritonavir 100 mg per 5 mL
Abbott Australasia Pty Ltd
Indication: For the treatment of HIV-infection in combination with other antiretroviral drugs in adults and children aged 2 years and older. Indication is based on analyses of plasma RNA levels and CD4 cell counts (see Clinical Trials). At present there are no results from controlled trials evaluating the effect of Kaletra on clinical progression of HIV".

TAZOCIN Piperacillin sodium/tazobactam
Sterile powder for reconstitution for intravenous or intramuscular injection, 2.25 g, 3.375 g and 4.5 g per vial
Wyeth Australia Pty Limited
Variation: Extension of approvedIndications to include "use in hospitalised children aged two months to 12 years. Tazocin is indicated for the treatment of serious intra-abdominal infections".

ZITHROMAX Azithromycin dihydrate
Tablets, 250 mg, 500 mg and 600 mg; powder for oral suspension, 200 mg
Pfizer Pty Limited
Variation: Revision of approved dosage regimen for the treatment of adult chlamydial conjunctival infections, trachoma and inclusion conjunctivitis to include single-dose treatment.

ARANESP Darbepoetin alfa [rch]
Sterile solution for subcutaneous or intravenous injection, 10 µg, 15 µg, 20 µg, 30 µg, 40 µg, 50 µg, 60 µg, 80 µg, 100 µg, 150 µg, 200 µg, and 300 µg in prefilled syringes, 15 µg, 25 µg, 40 µg, 60 µg, and 100 µg in vials
Amgen Australia Pty Ltd
Indication: For the treatment of anaemia associated with chronic renal failure (CRF).

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SINGULAIR Montelukast sodium
Tablet, 4 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: A new strength for use in the new age population of children aged 2-5 years for the treatment of chronic asthma.

FEMARA Letrozole
Tablets, 2.5 mg
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Extension ofIndications to include the first-line treatment of advanced breast cancer in post-menopausal women with hormone receptor-positive cancer and cancer of unknown hormone receptor status.

VESTRA Reboxetine mesylate
Tablets, 2 mg and 4 mg
Pharmacia Australia Pty Limited
Indication: Vestra is indicated for the treatment of major depression and is effective in preventing the relapse of depressive symptoms.

DYSPORT Clostridium botulinum type A toxin - haemagglutinin complex
Sterile powder for reconstitution for intramuscular injection, 500 Ipsen units
O'Shea and Associates, on behalf of Ipsen Pty Limited
Variation: Extension ofIndications to include the treatment of spasticity of the arm in adults following a stroke.

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SOMAC Pantoprazole sodium sesquihydrate
Tablets, 20 mg
Pharmacia Australia Pty Limited
Variation: Extension of Indications to amend the wording for gastro-oesophageal reflux disease and to include the treatment of symptomatic reflux. The Indication should read as follows:

"Gastro-oesophageal reflux disease (GORD)"

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

LIORESAL INTRATHECAL Baclofen
Sterile solution for intrathecal injection, 0.05 mg/1 mL, 10 mg/20 mL, 10 mg/5 mL ampoules
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Extension ofIndications to include severe chronic spasticity of cerebral origin.

ZYPREXA IM Olanzapine
Sterile powder for reconstitution for intramuscular injection, 10 mg/vial with or without 1 mL sterile sodium chloride solution (0.33% w/v) in prefilled syringe
Eli Lilly Australia Pty Limited
Variation: New dosage, new route of administration and new Indication of "for the rapid control of agitation and disturbed behaviours in patients with schizophrenia and related psychoses and in patients with acute mania associated with bipolar disorder I, when oral therapy is not appropriate".

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TEVETEN Eprosartan
Tablets, 200 mg, 300 mg, 400 mg and 600 mg
Solvay Biosciences Pty Ltd
Variation: Amendment of Dosage and Administration section of Product Information

STARLIX Nateglinide
Tablets, 60 mg, 120 mg, and 180 mg
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For the treatment of patients with diabetes mellitus type 2 (NIDDM) whose hyperglycaemia cannot be controlled by diet and physical exercise. Nateglinide can be used as monotherapy or in combination with metformin.

VALETTE/VALETTE ED Dienogest/ethinyloestradiol
VALETTE: 21 sugar-coated tablets, containing dienogest 2 mg plus ethinyloestradiol 30 µg;
VALETTE ED: 21 tablets as per Valette, plus 7 placebo tablets
Schering Pty Limited
Indication: For use as an oral contraceptive.

YASMIN Drospirenone/ethinyloestradiol
Combination pack consisting of 21 active tablets, containing drospirenone 3 mg and ethinyloestradiol 0.03 mg, and 7 inactive placebo tablets.
Schering Pty Limited
Indication: For use as an oral contraceptive.

DIAMICRON MR Gliclazide
Modified-release tablets, 30 mg
Servier Laboratories (Australia) Pty Ltd
Variation: New dosage regimen, new strength and new dose form for "Type 2 diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose".

The ADEC also resolved to advise the Minister and the Secretary on the following issue relating to vaccine products:

RESOLUTION NO 8056

The ADEC recommended that the product informations and consumer medicine informations for all vaccine products produced using bovine serum sourced from countries where BSE has been reported (including the UK) should contain statements which reflect the assessed potential risk of transmissible spongiform encephalopathy (TSE), in line with the current findings of the NHMRC and the FDA.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

April 2001

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