Meeting date | Active Ingredient Name | Summary | Outcome |
---|---|---|---|
22 March 2023 | Semaglutide solution for injection, pre-filled pen | Trade names Ozempic® and Wegovy® The sponsor asked that the decision made by the Australian Commission of Quality and Safety in Health Care’s advisory group in October 2022, that semaglutide does not meet principles for inclusion in either list, is re-considered. The AIPWG did not have sufficient detail as to why the sponsor is requesting a re-consideration of the Commission’s decision. The Department will clarify with the sponsor it’s reasons for reconsideration against published principles. | Deferred to next meeting in July 2023 |
22 March 2023 | Acetic acid, oxyquinoline sulfate and ricinoleic acid vaginal gel | Trade name Aci-Jel® Balance Vaginal Gel Product is available through the RPBS under ‘other gynecologicals’. There are similar items listed in the LEMI for practicality. | Include in LEMI for practicality |
22 March 2023 | Gelatin, pectin and carmellose sodium paste | Trade name Orabase® Product is available through the RPBS under ‘emollients and protectives’. There are similar items listed in the LEMI for practicality. | Include in LEMI for practicality |
26 July 2023 | Semaglutide solution for injection, pre-filled pen | Semaglutide products were reconsidered in July AIPWG. Trade names, Ozempic® and Wegovy® have different devices, i.e., multi use and single use pens and for different indications, i.e., weight loss and diabetes There is a risk of confusion and patient safety | Include in LMBC on basis of principle 8, differences in administration/delivery devices Include in LMBC |
26 July 2023 | Ciclosporin eye drops Available in 0.09%, 0.1%, 0.05% | Trade names Cequa®, Ikervis®, Restasis® Confusion can occur while prescribing and dispensing. | Include in LMBC on basis of principle 7, similarity of active ingredient names
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26 July 2023 | 1 mg of estradiol (as hemihydrate) and 100 mg of progesterone capsule | Trade name: Bijuva® 1/100 There is potential for confusion with other hormone replacement therapy (HRT) products. All hormonal contraceptive pills are on LMBC | Include in LMBC on basis of principle 7, similarity of active ingredient names |
26 July 2023 | Misoprostol, 25 micrograms tablet | Trade name: Angusta® There is a risk of confusion between misoprostol brands. Other higher strengths, misoprostol 200mcg products, Cytotec and Gymiso, are already on LMBC | Angusta® meet principle 7, similarity of active ingredient names Include in LMBC |
26 July 2023 | Lenalidomide capsule and pomalidomide capsule | Each company/brand are having a separate risk management program, to ensure that pregnant women are not prescribed or supplied the medicine. At its out of session October 2022 meeting, the Pharmaceutical Benefits Advisory Committee recommended that bioequivalent brands of lenalidomide and equivalent brand of pomalidomide should not be considered equivalent for the purposes of substitution on the PBS for practicality reasons. (Not ‘a’ flagged) | Lenalidomide and pomalidomide meet principle 9, Highly Specialised Drugs. Include in LMBC |
26 July 2023 | Estradiol + norethisterone acetate available in 50/140 and 50/250 patch, 8. | Trade names: Estalis Continuous 50/140 and Estalis Continuous 50/250 Estalis Sequi 50/140 and 50/250 are on LMBC. Estalis continuous 50/140 and 50/250 have same active ingredient and within the same product range of Estalis Sequi that can be confused with. | Include in LMBC |
26 July 2023 | Estradiol 1mg + dydrogesterone 5mg tablet | Trade name: Femoston-Conti Femoston 1/10 mg and 2/10 mg tablets are both on the LMBC Femoston-Conti has same active ingredient and within the same product range of Femoston that can be confused with. | Include in LMBC |
26 July 2023 | Betamethasone (as dipropionate) 0.05% cream and ointment, 15g | Trade names: Diprosone ointment and cream Eleuphrat ointment and cream Diprosone OV ointment and cream are on the LMBC. Diprosone and Eleuphrat ointment and cream has same active ingredient and within the same product range of Diprosone OV that can be confused with. | Include in LMBC |
26 July 2023 | Budesonide – formoterol powder for inhalation 400 mcg/12mcg /actuation | Trade names: Symbicort Turbuhaler, Rilast Turbuhaler, Biresp Spiromax and Duoresp Spiromax Spiromax® and Turbuhaler® devices are both dry powder inhalers but they are designed differently and have different instructions for use 200 microgram-6 microgram strength of these inhalers is on the LMBC Delivery device continuity required | Include in LMBC |
26 July 2023 | Amphotericin B (amphotericin) 50mg powder for injection vial | Trade names: Amphotericin Liposomal RAN, Amphotericin Liposomal RBX and Amphotericin Liposomal SUN AmBisome amphotericin B (liposomal amphotericin 50 mg) and Amphotericin B Mylan (amphotericin B 50 mg) are on the LMBC. Rules apply to all TGA registered brands of amphotericin | Include in LMBC |
26 July 2023 | Levothyroxine sodium 50, 75, 100, 125, 200 microgram tablet | Trade names: Levothox, Levothyroxine Sandoz, Levothryoxine GH, Thyrox, Oroxine, Eutroxsig, Levoxine and Eltroxin are on the LMBC Rules apply to all TGA registered levothyroxine brands | Include in LMBC |
26 July 2023 | Mycophenolic acid (as sodium) 180, 360 mg enteric coated tablet | Trade names: Mycophenolic Acid ASTRON, Mycophenolic acid INTAS, Mycophenolic acid Accord, Mycophenolic acid ARX Myfortic brand of mycophenolate mofetil 180 mg and 360 mg enteric coated tablets is also available on the LMBC Rules apply to all TGA registered Mycophenolate brands | Include in LMBC |
22 November 2023 | Abiraterone acetate 125mg and methylprednisolone 4 mg tablet | Trade names: Yonsa Mpred Rules apply to only the TGA registered Yonsa Mpred brand. Availability of the single and composite pack may cause confusion.
| Include in LMBC on basis of principle 7, similarity of active ingredient names |
22 November 2023 | Monobasic sodium phosphate (161mg/mL) + dibasic sodium phosphate heptahydrate (59.3mg/mL) enema | Trade names: Fleet Ready-To-Use enema Rules apply to all TGA registered Fleet brands Does not meet principles for inclusion in the LEMI; recommended to be included in LMBC. | Include in LMBC |
22 November 2023 | Risedronate sodium, 35mg enteric coated tablet | Trade names: Actonel EC Rules apply to only the TGA registered Actonel EC brand Differences in release characteristics between brands with the same active ingredient and strength. | Include in LMBC |
22 November 2023 | Betacarotene 0.0002 g + Ispaghula Husk Dry 3.5 g sachet | Trade names: Fybogel Apart from the product being an RPBS item, no other principles were met for inclusion in the LEMI. There are no patient safety risks. | Not recommended for inclusion in LEMI |
22 November 2023 | Psyllium Husk Powder 3.4g/7 g powder for oral liquid, 504 g
| Trade names: Metamucil Natural Granular Apart from the product being an RPBS item, no other principles were met for inclusion in the LEMI. There are no patient safety risks | Not recommended for inclusion in LEMI |
22 November 2023 | Macrogol-3350, 1g/g, 510g, powder for oral liquid | Trade names: OsmoLax Apart from the product being an RPBS item, no other principles were met for inclusion in the LEMI. There are no patient safety risks. | Not recommended for inclusion in LEMI |
29 October 2024 | Melatonin prolonged release tablet 1 mg and 5 mg | Trade name: Slenyto Different formulation exists for different indications, with the same strength (Voquily immediate release capsules 5mg indicated for children 6-18 years while Slenyto prolonged release tablet 5 mg is indicated for children 2 – 18 years). The active ingredient of melatonin meets the principles for inclusion in the LMBC - different formulation, same active, different indications or dosing regimens or different release characteristics. | Include in LMBC |
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