You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ADEC 213th meeting resolutions, 7-8 December 2000

Australian Drug Evaluation Committee

7 December 2000

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 213th (2000/6) meeting of the Australian Drug Evaluation Committee (ADEC) (7-8 December 2000) 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.

HEMABATE Carboprost trometamol
Sterile solution for intramuscular injection, 250 µg/mL in 1 mL ampoules.
Pharmacia Australia Pty Limited
Indication: For the treatment of post-partum haemorrhage due to uterine atony which has not responded to conventional management.

NOVOMIX 30 Insulin aspart (rys)
Sterile biphasic suspension for subcutaneous injection, 100 IU/mL (consisting of 30% soluble insulin aspart and 70% protamine-bound insulin aspart) in 10 mL vials and 1.5 mL and 3 mL prefilled syringes and cartridges.
Novo Nordisk Pharmaceuticals Pty Ltd
Variation: A new fixed combination for the treatment of diabetes mellitus.

PREMIA 10 Conjugated oestrogens/ medroxyprogesterone acetate
Composite pack containing 14 sugar-coated tablets of conjugated oestrogens 0.625 mg and 14 sugar-coated tablets of combined conjugated oestrogens 0.625 mg with medroxyprogesterone acetate 10 mg
Wyeth Australia Pty Limited
Variation: A new fixed combination:

  1. As replacement therapy for oestrogen deficiency states associated with the climacteric in women with an intact uterus; and
  2. For the prevention and management of osteoporosis.

FOSAMAX Alendronate
sodium Tablets, 70 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: A new dosage regimen and new strength for the treatment of post-menopausal osteoporosis.

FOSAMAX Alendronate
sodium Tablets, 5 mg, 10 mg and 40 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: Amendment of the Product Information.

Top of page

KEPPRA Levetiracetam
Film-coated, unscored tablets, 250 mg, 500 mg, 750 mg and 1000 mg
UCB Australia Pty Ltd
Indication: For use in epileptic patients aged 12 years and older, initially as add-on therapy, in the treatment of partial onset seizures, with or without secondary generalisation.

ESMERON Rocuronium bromide
Sterile solution for intravenous injection, 10 mg/mL in 5 mL and 10 mL ampoules and 5 mL, 10 mL and 25 mL vials
Organon Teknika Australia Pty Limited
Variation: Extension ofIndications to include use as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

ULTIVA Remifentanil hydrochloride
Sterile powder for reconstitution for intravenous injection, 1 mg, 2 mg and 5 mg
Glaxo Wellcome Australia Ltd
Variation: A new patient population, new dosage regimen and new Indication, as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years, and for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery.

IMIGRAN/IMIGRAN S Sumatriptan
Nasal spray, 20 mg/0.1 mL; 10 mg/0.1 mL
Glaxo Wellcome Australia Ltd
Variation: A new patient population for the acute relief of migraine attacks with or without aura in adolescents aged 12 to 17 years

Top of page

IOMERON 200/IOMERON 300
Iomeron 200, sterile solution for intravenous injection containing iomeprol 408.2 mg/mL in 50 mL, 75 mL, 100 mL, 150 mL and 200 mL vials;
Iomeron 300, sterile solution for intravenous injection, containing iomeprol 612.4 mg/mL in 20 mL, 50 mL, 75 mL, 100 mL, 150 mL and 200 mL vials
Bracco Pty Ltd
Variation: Extension ofIndications to include use in myelography in adults.

ULTRAVIST 240 Iopromide
Sterile solution for intrathecal injection, 499 mg/mL (corresponding to 240 mg/mL of iodine) in 10 mL bottles
Schering Pty Limited
Variation: Extension ofIndications to include use for lumbar myelography in adults.

PREVENAR Pneumococcal conjugate vaccine, 7-valent
Sterile suspension for intramuscular injection, 0.5 mL single-dose vials containing capsular polysaccharides of Streptococcus pneumoniae serotypes 4, 6B, 9V 14, 18C, 19F and 23F individually conjugated to diphtheria CRM197 protein
Wyeth Australia Pty Limited
Indication: For the active immunisation of infants and children from 6 weeks to 9 years of age against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae.

LEVOVIST Galactose/palmitic
Sterile powder for reconstitution for intravenous injection, each gram of Levovist contains 999 mg galactose and 1 mg palmitic acid; 20 mL vials containing 2.5 g or 4 g
Schering Pty Limited
Variation: Extension ofIndications to include harmonic imaging for B-mode echocardiography.

Top of page

ZANIDIP Lercanidipine hydrochloride
Film-coated tablets, 10 mg
Kendle Research & Development Pty Ltd
Indication: For the treatment of mild to moderate hypertension.

ORZEL Tegafur/Uracil, calcium folinate
Combination pack containing UFT capsules (tegafur 100 mg and uracil 224 mg) and calcium folinate tablets, 15 mg
Bristol-Myers Squibb Australia Pty Ltd
Indication: For the first-line treatment of metastatic colorectal cancer.

ELOXATIN Oxaliplatin
Sterile powder for reconstitution for intravenous injection, 50 mg and 100 mg
Sanofi-Synthelabo Australia Pty Limited
Indication: For second-line treatment of advanced colorectal cancer, in combination with 5-fluorouracil and folinic acid.

NEXIUM Esomeprazole magnesium trihydrate
Tablets, 20 mg and 40 mg AstraZeneca Pty Ltd
Indication:

  1. For gastro-oesophageal reflux disease (GORD),
    • Treatment of erosive oesophagitis,
    • long-term management of patients with healed oesophagitis to prevent relapse, and
    • symptomatic treatment of GORD.
  2. In combination with appropriate antibiotics for:
    • healing of duodenal ulcer associated with Helicobacter pylori, and
    • eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

CELLCEPT Mycophenolate mofetil
Capsules, 250 mg, tablets, 500 mg, powder for oral suspension, 200 mg/mL and sterile powder for intravenous injection, 500 mg
Roche Products Pty Limited
Variation: Extension ofIndications to include prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.

PRO-EPANUTIN Fosphenytoin sodium
Sterile solution for intravenous or intramuscular injection, 75 mg/mL in 2 mL and 10 mL vials
Parke Davis Pty Ltd
Variation: Extension of the patient population to include paediatric patients aged 0 to 5 years, and to amend the overdosage section of the product information.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

15 December 2000

Top of page