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ADEC 223rd meeting resolutions, 1-2 August 2002

Australian Drug Evaluation Committee

1 August 2002

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 223rd (2002/4) meeting of the Australian Drug Evaluation Committee (ADEC) (1-2 August 2002) 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.

RISEDRONATE SODIUM Actonel
Tablets, 5 mg
Aventis Pharma Pty Limited
Variation: Extension of indications to include the treatment of osteoporosis (instead of treatment of postmenopausal osteoporosis).

METHYLPHENIDATE HYDROCHLORIDE Ritalin LA
Modified-release capsules, 20 mg, 30 mg and 40 mg
Novartis Pharmaceuticals Australia Pty Limited
Indication: For the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

PANTOPRAZOLE Somac and Pantoloc
Enteric-coated tablets, 20 mg and 40 mg
Pharmacia Australia Pty Limited
Indication: Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism.

RISPERIDONE Risperdal
Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg. Oral solution 1 mg /1 mL
Janssen-Cilag Australia Pty Ltd
Variation: Extension of indications to include the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with subaverage intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent.

FLUOXETINE HYDROCHLORIDE Prozac, Lovan, Erocap, Erotab
Prozac, capsules, tablets and liquid
Lovan, capsules, tablets and liquid
Erocap, capsules
Erotab, tablets
Eli Lilly Australia Pty Limited
Variation: The new (additional) dosage schedule for Premenstrual Dysphoric Disorder (PMDD) is 20 mg/day given continuously (every day of the menstrual cycle) or intermittently (defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle).

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MENINGOCOCCAL GROUP C POLYSACCHARIDE CONJUGATE VACCINE NeisVac C
Suspension for intramuscular injection, containing 10 µg meningococcal group C polysaccharide conjugated to 10 to 20 µg of tetanus toxoid, in 0.5 mL single-dose vials
Baxter Healthcare Pty Limited
Indication: For active immunisation of children from 6 weeks of age, adolescents and adults, for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.

PERTUSSIS VACCINE ACELLULAR COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) AND INACTIVATED POLIOVIRUS TYPES 1,2 & 3 (MRC-5) Quadracel
Suspension for injection, in 0.5 mL vial
Aventis Pasteur Pty Limited
Indication: For the primary immunisation of children from 2 months to 12 months against diphtheria, tetanus, whooping cough and poliomyelitis. The recommended schedule is at 2, 4 and 6 months and a fourth dose administered from 15 months to 6 years of age.

COMBINATION VACCINE PACK CONTAINING PERTUSSIS VACCINE ACELLULAR COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) AND INACTIVATED POLIOVIRUS TYPES 1,2 & 3 (MRC-5), AND HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE Poliacel
Act-HIB® lyophilised Haemophilus influenza type b conjugate vaccine in vial for reconstitution with Quadracel™ suspension for injection.
Aventis Pasteur Pty Limited
Indication: For the primary immunisation of children from 2 months to 12 months against diphtheria, tetanus, whooping cough, poliomyelitis and Haemophulus influenzae type b disease and for a fourth dose administered from 15 to 20 months of age.

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PERTUSSIS VACCINE COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED), INACTIVATED POLIOVIRUS TYPES 1,2 & 3 (VERO CELL), AND HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE Pediacel
Suspension for injection, in 0.5 mL pre-filled syringe or vial
Aventis Pasteur Pty Limited
Indication: For the primary immunisation of children from 2 months to 12 months against diphtheria, tetanus, whooping cough, poliomyelitis and invasive Haemophilus influenzae type b disease. The recommended schedule is at 2, 4 and 6 months and a fourth dose administered from 15 to 20 months of age.

COMBINED SALMONELLA TYPHI VI POLYSACCHARIDE AND INACTIVATED HEPATITIS A VIRUS VACCINE Vivaxim
Combination vaccine for intramuscular injection, containing Salmonella typhi Vi capsular polysaccharide 25 µg and inactivated hepatitis A virus 160 antigen units, in a 1.0 mL dual chamber syringe
Aventis Pasteur Pty Limited
Indication: For simultaneous active immunisation against typhoid fever and hepatitis A virus infections in subjects from 16 years of age.

MENINGOCOCCAL C CONJUGATE VACCINE Menjugate
Powder for injection, containing 10 micrograms of meningococcal group C polysaccharide conjugated to diphtheria CRM197 protein 12.5 to 25 µg, with 0.5 mL diluent vial
Delpharm Consultants Pty Limited
Indication: For active immunisation of children from 6 weeks of age, adolescents and adults, for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.

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5 % PHENOL IN ALMOND OIL Oily Phenol Injection BP
Injection
F H Faulding & Co Limited
Indication: For the treatment of symptomatic haemorrhoids in patients with an inadequate response to conservative therapy such as dietary manipulation. It must only be injected submucosally and its use is usually confined to first degree or second degree haemorrhoids.

TADALAFIL Cialis
Tablets, 10 mg, 20 mg
Eli Lilly Australia Pty Ltd
Indication: For the treatment of erectile dysfunction in adult males. Cialis is not indicated for use by women.

ETORICOXIB Arcoxia
Tablets, 60 mg, 90 mg and 120 mg
Merck Sharp & Dohme Australia Pty Ltd
Indications: For the:

  • Treatment of the symptoms and signs of osteoarthritis (OA)
  • Treatment of acute gouty arthritis
  • Treatment of primary dysmenorrhea
  • Relief of acute pain related to minor dental procedures.

VALDECOXIB Valdyne
Tablets, 10 mg, 20 mg and 40 mg
Pharmacia Australia Pty Limited
Indications: For the:

  • Symptomatic treatment of osteoarthritis and rheumatoid arthritis
  • Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures
  • Treatment of mild to moderate post-operative pain.

PEGFILGRASTIM (rbe) Neulasta
Injection solution, 6 mg/ 0.6 mL in a ready-to-use syringe
Amgen Australia Pty Ltd
Indication: For the treatment of patients with cancer following chemotherapy to decrease the duration of severe neutropenia, and so reduce the incidence of infection as manifested by febrile neutropenia.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

16 August 2002

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