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ADEC 245th meeting resolutions, 30-31 March 2006

Australian Drug Evaluation Committee

30 March 2006

Published in the Commonwealth of Australia Gazette, No. GN 16, 26 April 2006

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 245th meeting of the Australian Drug Evaluation Committee (ADEC) (30-31 March 2006) 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.

PERTUSSIS (ACELLULAR) AND DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) COMBINED WITH INACTIVATED POLIOVIRUS TYPES 1, 2 AND 3 (VERO CELL) VACCINE 0.5mL
Adacel Polio
Injection
Sanofi Pasteur Pty Ltd
New Strength & New Dosage and Administration - The active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged four years and older who have already received four doses of DTPa and IPV or OPV.

TIGECYCLINE 50mg
Tygacil
Powder for injection
Wyeth Australia Pty Limited
New Chemical Entity - The treatment of the following infections in adults.

  • Complicated skin and skin structure infections, including those with methicillin-resistant Staphylococcus aureus (MRSA), where there is suspected or proven resistance to, or intolerance of other available agents, or there are co-morbidities preventing its use.
  • Complicated intra-abdominal infections, where there is suspected or proven resistance to, or intolerance of other available agents, or there are co-morbidities preventing its use.

OLMESARTAN MEDOXOMIL / HYDROCHLOROTHIAZIDE 20/12.5mg, 20/25mg & 40/25mg
Olmetec Plus
Tablets
Pfizer Australia Pty Ltd
New Fixed Dose Combination - The treatment of mild to moderate hypertension not responding to monotherapy.

SOLIFENACIN SUCCINATE 5mg & 10mg
Vesicare
Tablets
Ballia Holdings Pty Ltd
New Chemical Entity - The treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

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SILDENAFIL (AS CITRATE) 20mg
Revatio
Tablet
Pfizer Australia Pty Ltd
New Indication - The treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity.

PALONOSETRON HYDROCHLORIDE 0.25 µg/5mL
Onicit
Solution for injection
Schering Plough Pty Limited
New Chemical Entity - The prevention of nausea and vomiting induced by cytotoxic chemotherapy.

ALEMTUZUMAB (RCH) 30mg/mL
Mabcampath
Solution for injection (infusion)
Schering Pty Limited
New Chemical Entity - The treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) who have relapsed and after failure of at least two prior therapies.

EXEMESTANE 25mg
Aromasin
Tablet
Pfizer Australia Pty Ltd
New Indication - For the sequential adjuvant treatment of early oestrogen receptor-positive breast cancer in post-menopausal women who have received prior adjuvant tamoxifen therapy.

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DEFERASIROX 125mg, 250mg & 500mg
Exjade
Tablets (dispersible)
Novartis Pharmaceuticals Australia Pty Ltd
New Chemical Entity - The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults, adolescents and in children 6 years and older;

and

The second line treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in paediatric patients aged 2 to 5 years who are intolerant to desferrioxamine or in whom desferrioxamine has proven ineffective.

TRASTUZUMAB 150mg
Herceptin
Powder for injection
Roche Products Pty Ltd
Product Information changes - To include additional information in the Product Information regarding the diagnosis of HER-2 positive breast cancer.

METHYL-5-AMINOLEVULINATE 160mg/g
Metvix
Cream
GALDERMA AUSTRALIA P/L
New Dosage Regimen - For the treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses (AK) on the face and scalp when other registered therapies are unacceptable.

CIPROFLOXACIN HYDROCHLORIDE 3mg/mL
Ciloquin / Ciloxan
Ear drops
Alcon Laboratories (Australia) Pty Ltd
New Indication & New Route of Administration - The treatment of chronic suppurative otitis media caused by organisms susceptible to ciprofloxacin in adults and children 1 month and older. The recommended dose is five drops into the affected ear canal(s) twice daily for nine days.

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ROSUVASTATIN 5mg, 10mg, 20mg & 40mg
Crestor/Visacor
Tablets
AstraZeneca
New Strength & New Dosage and Administration - An adjunct to diet when the response to diet and exercise is inadequate for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinurias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

DOXORUBICIN HYDROCHLORIDE 0.2%
Doxorubicin Injections
Solution for Injection
Genepharm Australasia
Generic - Doxorubicin has been used successfully to produce regression in neoplastic conditions such as acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin's and non- Hodgkin's types, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas and ovarian carcinoma.

Doxorubicin is also indicated by intravesical administration in the primary management of nonmetastatic carcinoma of the bladder (Tis, T1, T2).

TIPRANAVIR 250mg
Aptivus
Capsules
Boehringer Ingelheim Pty Ltd
New Chemical Entity - Co-administered with low-dose (200mg) ritonavir for combination treatment of HIV-1 infection in highly pre-treated adults with evidence of viral replication and HIV-1 strains confirmed resistant to multiple protease inhibitors.

ROTAVIRUS VACCINE LIVE ORAL PENTAVALENT 2mL
Rotateq
Oral Liquid
Merck Sharp & Dohme (Australia) Pty Limited
New Chemical Entity - The prevention of rotavirus gastroenteritis in infants

VARICELLA ZOSTER VIRUS VACCINE LIVE 19,400 PFU/0.65mL
Zostavax
Virus vaccine live
Merck Sharp & Dohme (Australia) Pty Limited
New Chemical Entity - The prevention of Herpes Zoster (shingles), for prevention of postherpetic neuralgia (PHN) and for reduction of acute and chronic zoster-associated pain in individuals 60 years of age or older.

14 April 2006

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