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ADEC 220th meeting resolutions, 7-8 February 2002

Australian Drug Evaluation Committee

7 February 2002

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 220th (2002/1) meeting of the Australian Drug Evaluation Committee (ADEC) (7-8 February 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.

BUDESONIDE/EFORMOTEROL Symbicort 200/6 and 100/6 Turbuhaler
Fixed combination dry powder inhalers, 200 mcg/6 mcg and 100 mcg/6 mcg per actuation
AstraZeneca Pty Ltd
Indication: Indicated for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β-agonist) is appropriate in adults and adolescents ≥ 12 years of age. This includes patients who are symptomatic on inhaled corticosteroid therapy and patients who are established on regular long acting β-agonist and inhaled corticosteroid therapy.

TIOTROPIUM BROMIDE MONOHYDRATE Spiriva
Capsules, powder for inhalation 22.5 mcg via the Handihaler device
Boehringer Ingelheim Pty Limited
Indication: Indicated for the long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD).

RITUXIMAB MabThera
Sterile solution for intravenous infusion, 100 mg/10 mL and 500 mg/50 mL vials
Roche Products Pty Ltd
Variation: Extension of indications to include the treatment of CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma in combination with chemotherapy.

FIBRIN SEALANT Tisseel DUO 500
Sterile deep frozen injection, 1 mL pre-filled syringe
Baxter Healthcare Pty Limited
Indication: Indicated for the for the following:

  • As an adjunct to haemostasis during surgical procedures, when control of bleeding by conventional surgical techniques is ineffective or impractical; and
  • As a sealant as an adjunct to the closure of colostomies.

ADAPALENE Differin
Topical solution, 1mg/mL
Galderma Australia Pty Ltd
Variation: To register the new dose form for the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest and back.

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CONJUGATED EQUINE OESTROGENS AND MEDROXYPROGESTERONE ACETATE Premia LD
Tablets, 0.3 mg/1.5 mg and 0.45 mg/1.5 mg
Wyeth Australia Pty Ltd
Variation: For use as replacement therapy for oestrogen deficiency states associated with the climacteric in women with an intact uterus most commonly manifested by moderate to severe vasomotor symptoms associated with oestrogen deficiency (sweating, hot flushes).

OLOPATADINE HYDROCHLORIDE Patanol
Eye Drops, 0.1% containing 1.0 mg/mL as a 5 mL dispenser
Alcon Laboratories (Australia) Pty Ltd
Indication: Indicated for the treatment of signs and symptoms of seasonal allergic conjunctivitis. The maximal treatment duration should be 14 weeks.

PAROXETINE AS HYDROCHLORIDE Aropax
Tablets, 20 mg and 30 mg, oral solution 20 mg/10 mL
GlaxoSmithKline Australia Pty Ltd
Variation: Extension of indications to include the treatment of posttraumatic stress disorder.

MODAFINIL Modavigil
Tablets, 100 mg
CSL Ltd
Indication: Indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

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MESALAZINE Salofalk
Enemas, 2 g/30 mL, 2 g/60 mL, and 4 g/60 mL, granules, 500 mg and 1 g sachets, bottle, 80 g multibose
Orphan Australia
Variation: New route of administration for Salofalk granules and enemas containing:

  1. Granules - mesalazine 500mg and 1g sachets and 80g multiple dose bottle for the treatment of acute ulcerative colitis of mild to moderate severity at a dose of 0.5g to 1.0g three times a day; and
  2. Enemas - mesalazine 2g/30mL, 2g/60mL, 4g/60mL for the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis at a dose of 2g or 4g once a day before going to bed.

BOTULINUM TYPE A TOXIN Botox
Sterile solution for injection, 100 U
Allergan Australia Pty Ltd
Variation: Extension of indications to include treatment of glabellar lines associated with corrugator and/or procerus muscle activity.

SULESOMAB KIT FOR THE PREPARATION OF 99MTC-SULESOMAB Leukoscan,
Sterile powder for injection, 0.31 mg/3 mL vials
Australian Radioisotopes Pty Ltd
Indication: Indicated for use in diagnostic imaging for the investigation of suspected osteomyelitis in long bones and in feet, including those with diabetic foot ulcers.

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DROTRECOGIN ALPHA Xigris
Sterile reconstituted powder for intravenous infusion 5 mg and 20 mg vials
Eli Lilly Pty Ltd
Indication: Indicated for the reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have high risk of death (eg. as determined by APACHE II, see Clinical Trials).

LAMIVUDINE 3TC
Film-coated tablets, 150 mg, oral solution 10 mg/mL
Smithkline Beecham Australia Pty Ltd
Variation: Extension of indications for use in combination anti-retroviral treatment of HIV infected children over 3 months of age.

INACTIVATED HEPATIS A AND HEPATITIS B VACCINE Twinrix
Sterile solution for intramuscular injection, 720 EU Hep A antigen and 20 µg Hep B antigen
SmithKline Beecham Australia Pty Ltd
Variation: Extension of indications of Twinrix inactivated Hepatitis A and Hepatitis B vaccine in a two dose primary schedule for subjects aged one to 15 years of age.

BISOPROLOL FUMARATE Bicor
Film-coated tablets, 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg
Alphapharm Pty Limited
Indication: Indicated for the treatment of stable, chronic, moderate to severe heart failure in addition to ACE inhibitors, and diuretics and optionally cardiac glycosides.

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AGALSIDASE BETA Fabrazyme
Sterile reconstitution powder for intravenous infusion, 35 mg/7 mL vials
Genzyme Australasia Pty Ltd
Indication: Indicated for enzyme replacement therapy in patients with Fabry Disease (a-galactosidase deficiency).

EPROSARTAN MESYLATE/HYDROCHLORIOTHIAZIDE Teveten Plus
Tablets, 600 mg plus 12.5 g
Solvay Pharmaceuticals
Indication: Treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

FONDAPARINUX Arixtra
Sterile subcutaneous injection, 2.5 mg in 0.5 mL pre-filled syringe
Sanofi-Synthelabo Australia Pty Ltd
Indication: For the prevention of venous thromboembolic events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee or hip replacement surgery.

TELMISARTAN Micardis
Tablets, 40 mg and 80 mg
Boehringer Ingelheim Pty Ltd
Variation: There are no objections to the inclusion in the Product Information of a statement that there are no significant pharmacokinetic interactions between telmisartan and simvastatin.

QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE Accuretic
Tablets, 10 mg/12.5 mg and 20 mg/12.5 mg
Pfizer Pty Ltd
Variation: For the treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

February 2002

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