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The resolutions for approval of medicines by the ACPM are recommendations for further action by the TGA and do not constitute approvals in their own right.
THERAPEUTIC GOODS ACT 1989
ADVISORY COMMITTEE ON PRESCRIPTION MEDICINES
RECOMMENDATIONS
The 270th (2010/3) meeting of the Advisory Committee on Prescription Medicines (3rd & 4th June 2010) 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.
RESOLUTION 9424
- The ACPM recommended approval of the submission from Janssen-Cilag Pty Ltd to register a new salt of a previously approved active, paliperidone palmitate (INVEGA SUSTENNA), modified release aqueous solution for injection 25 mg, 50 mg, 75 mg, 100 mg, 150 mg for the indication:
- Acute and maintenance treatment of schizophrenia in adults
RESOLUTION 9425
- The ACPM recommends approval of the submission from Servier Laboratories Australia Pty Ltd to register a new chemical entity, agomelatine (VALDOXAN) film coated tablets 25 mg, for the indication:
- Treatment of major depression in adults including prevention of relapse
RESOLUTION 9426
- The ACPM recommended approval of the submission from Merck Sharp & Dohme Australia Pty Ltd to extend the indication for quadrivalent human papillomavirus recombinant vaccine (GARDASIL) 20, 40, 40, 20 µg / 0.5 mL to include the indication:
- GARDASIL is indicated in males aged 9 through 26 years for the prevention of external genital lesions and infection caused by Human Papillomavirus (HPV) Types, 6, 11, 16 and 18 (which are included in the vaccine).
- * Immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations. Gardasil should be administered as 3 separate 0.5 mL doses in a 0, 2 and 6 month schedule.
RESOLUTION 9427
The ACPM recommended approval of the submission from GlaxoSmithKline Australia Pty Ltd to register a new chemical entity, combined meningococcal group c and haemophilis influenzae type b conjugate vaccine (MENITORIX) injection containing:
- H. influenzae type b (strain S20752) polysaccharide antigen (polyribose ribitol phosphate 5 µg) conjugated to tetanus toxoid (12.5 µg) - PRP-TT.
- Neisseria meningitidis serogroup C (strain C11) polysaccharide antigen (5 µg) conjugated to tetanus toxoid (5 µg) - PSC-TT.
or the indication:
- Prevention of invasive diseases caused by H. influenzae type b and Neisseria meningitidis serogroup C
RESOLUTION 9429
- The ACPM recommended approval of the submission from Pfizer Australia Pty Ltd to register a new formulation and new indication, Tranexamic acid (CYKLOKAPRON) solutions for injection 100mg / ml, for the indication:
- For the reduction of peri- and post-operative blood loss and of the need for blood transfusion in adult patients undergoing cardiac surgery or total knee or hip arthroplasty; and paediatric patients undergoing cardiac surgery.
RESOLUTION 9430
- The ACPM recommended approval of the submission from Novartis Pharmaceuticals Pty Ltd to register new fixed combination strengths for amlodipine (as besylate) and valsartan (EXFORGE/EJOCIA) tablets 5 / 320 mg and 10 / 320 mg film coated tablets, for the indication:
- Exforge / Ejocia is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
RESOLUTION 9431
- The ACPM recommended approval of the submission from Abbott Products Pty Ltd to register a new chemical entity of for omega-3-acid ethyl esters 90 (OMACOR) soft capsule 1000 mg for the indication:
- Post Myocardial Infarction: Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet medicinal products, beta-blockers, ACE inhibitors).
- Hypertriglyceridaemia: Endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response. Treatment is indicated for the following types of dyslipidaemia (Fredrickson classification) only:
- Types IV & V as monotherapy and with close monitoring of LDL-C levels
- Type IIb as add-on therapy to statins, when control of triglycerides with statins has been shown to be insufficient
- Patients with higher baseline levels of triglycerides are more likely to exhibit a better response to OMACOR. OMACOR is not indicated in exogenous hypertriglyceridaemia (Type I hyperchylomicronaemia). There are insufficient data to support the use in patients with secondary endogenous hypertriglyceridaemia including patients with diabetes mellitus.
RESOLUTION 9432
- The ACPM recommended approval of the submission from Baxter Healthcare Pty Ltd to register the new chemical entity fibrin sealant frozen 4 IU (ARTISS) Topical 2 mL, 4 mL and 10 mL two-component solution, for the indication:
- For use in adhering autologous skin grafts in burns patients. Artiss is not indicated for haemostasis.
RESOLUTION 9433
- The ACPM recommended approval of the submission from Ipsen Pty Ltd to register a new strength of triptorelin (as embonate) (DIPHERELINE) solution for intramuscular injection 22.5 mg, for the indication:
- Treatment of Locally advanced or metastatic prostate cancer
RESOLUTION 9434
- The ACPM recommended approval of the submission from AstraZeneca Pty Ltd to register an extension of indication for gefitinib (IRESSA) tablets 250 mg to include the indication:
- For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), whose tumours express activating mutations of the EGFR TK (tyrosine kinase).
RESOLUTION 9435
- The ACPM recommended approval of the submission from Abbott Australasia Pty Ltd to register the new strength for leuprorelin acetate LUCRIN XL DEPOT 30 mg for subcutaneous administration, for the indication:
- for palliative treatment of locally extensive or metastatic prostate cancer (Stage C and D).
RESOLUTION 9438
- The ACPM recommended approval of the submission from Novartis Pharmaceuticals Pty Ltd to register the new chemical entity, indacaterol as maleate (ONBREZ BREEZHALER / ARBEELA BREEZHALER) inhaler 150 µg and 300 µg; for the indication:
- For a once daily, maintenance bronchodilator for long-term use to improve airflow limitation in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD).
RESOLUTION 9439
- The ACPM recommended approval of the submission from Schering-Plough Pty Limited to register a new chemical entity, corifollitropin alfa (ELONVA) solutions for injection 100 µg / 0.5 mL and 150 µg / 0.5 mL for the indication:
- Controlled ovarian stimulation (COS) for the development of multiple follicles and pregnancy in women participating in invitro fertilisation techniques.
RESOLUTION 9440
- The ACPM recommended approval of the submission from Sanofi Pasteur Pty Ltd to register the new chemical entity of Japanese encephalitis vaccine (live, attenuated) (IMOJEV) 4.0 - 5.8 log10 plaque forming units (PFU) of recombinant JE virus per 0.5 mL dose, for the indication:
- The prophylasis of Japanese encephalitis caused by Japanese encephalitis virus in individuals from 12 months of age and older.
- The recommended dose in individuals 12 months and older is a single 0.5 mL dose administered by subcutaneous injection.
RESOLUTION 9441
- The ACPM recommended approval of the submission from CSL Limited to register the new chemical entity, human fibrinogen (plasma-derived) (RIASTAP) powder for injection 1 g, for the indication:
- Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia.
RESOLUTION 9442
- The ACPM recommended approval of the submission from UCB Australia Pty Ltd to register two new strengths of rotigotine (NEUPRO) transdermal patch 1 mg / 24 hours and 3 mg / 24 hours to include the indication:
- The symptomatic treatment of moderate to severe idiopathic Restless Leg Syndrome in adults.
RESOLUTION 9443
- The ACPM recommended approval of the submission from Sanofi-Aventis Australia Pty Ltd to register the new chemical entity, dronedarone (MULTAQ) 400 mg tablets, for the indication:
- To reduce the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted, on top of standard therapy (see Clinical Trials)
11 June 2010
Donna Daniell
Secretary
ACPM