Determination under paragraph 98C (1) (b) (No. PB 50 of 2006)
as amended
made under the
National Health Act 1953
This compilation was prepared on 1 February 2007
taking into account amendments up to No. PB 9 of 2007
Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General’s Department, Canberra
Pharmaceutical Benefits
Determination under paragraph 98C (1) (b)
No. PB 50 of 2006 [see Note 1]
- This Determination commences on 1 December 2006.
2. Determination No. PB 32 of 2006 under paragraph 98C(1)(b) of the National Health Act 1953, made on 26 July 2006 with effect from 1 August 2006, is repealed.
3. In this Determination:
“Act” means the National Health Act 1953;
“approved price to pharmacists” has the same meaning as in subsection 98B(3) of the Act;
“Commonwealth price” has the same meaning as in subsection 84(1) of the Act;
“extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit;
“prescription” includes a prescription written on an authority prescription pursuant to regulation 13 of the Regulations, subparagraph 14(d) of the declaration made under subsection 85(2) of the Act or subparagraph 11(d) of the determinations made under sections 85, 85A and 88 of the Act, a repeat authorisation or a deferred supply authorisation;
“ready-prepared pharmaceutical benefit” means a drug or medicinal preparation in respect of which there is in force a determination under subsection 85(6) of the Act;
“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act;
“standard formula preparation” means an extemporaneously-prepared pharmaceutical benefit that is listed in Schedule 5 to this Determination.
4. For the purpose of the determination made under subsection 98B(1) of the Act:
(a) pharmaceutical benefits that involve the admixture of ready-prepared ingredients are set out in Schedule 1 to this Determination;
(b) drugs that are used in the preparation of extemporaneously-prepared pharmaceutical benefits and that are unstable or packed sterile and unused quantities of which are unsuitable for future use are set out in Schedule 2 to this Determination;
(c) pharmaceutical benefits that are classified as dangerous drugs for the purpose of payment of a dangerous drug fee are set out in Schedule 3 to this Determination;
(d) pharmaceutical benefits the complete pack of which shall be supplied regardless of any lesser quantity ordered are set out in Schedule 4 to this Determination.
5. Where a prescription identifies the ready-prepared pharmaceutical benefit to be supplied by reference to a particular brand, the amount payable shall be based on the approved price to pharmacists for that brand.
6. Where a prescription does not identify the ready-prepared pharmaceutical benefit to be supplied by reference to a particular brand, the amount payable shall be based on the approved price to pharmacists of the brand of that benefit, being a brand which is available from a wholesale source in the capital city of the State in which the benefit is supplied, for which the Commonwealth price for the supply of the benefit is lowest.
7. Where a prescription calls for a quantity of one of the pharmaceutical benefits listed in Schedule 4 to this Determination that is less than the quantity contained in the size of unit included in the particulars specified in the column headed ‘Form’ in that Schedule in relation to that benefit, the complete pack shall be supplied.
8. A medicinal preparation that is a variation of a standard formula preparation, due to the addition or deletion of an ingredient or to variation of the dose, or that is a combination of standard formula preparations, shall be deemed not to be a standard formula preparation.
9. An election made pursuant to paragraph 38 of the determination made under subsection 98B(1) of the Act shall be made in writing to the Chief Executive Officer of Medicare Australia and shall remain in force for a period of not less than 3 months from and including the date of election, but may be revoked in writing at any time after the expiration of that period; and while the election remains in force, the amount payable to the approved pharmacist or approved medical practitioner, in respect of the supply of an extemporaneously-prepared pharmaceutical benefit that is not a standard formula preparation, shall be the amount calculated in accordance with paragraph 21 of the determination made under subsection 98B(1) of the Act.
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP | Powder for oral suspension equivalent to 125 mg amoxycillin-31.25 mg clavulanic acid per 5 mL, 75 mL |
| Powder for oral suspension equivalent to 400 mg amoxycillin-57 mg clavulanic acid per 5 mL, 60 mL |
Amoxycillin Trihydrate with Water - Purified BP | Powder for paediatric oral drops equivalent to 100 mg amoxycillin per mL, 20 mL |
| Powder for oral suspension equivalent to 125 mg amoxycillin per 5 mL, 100 mL |
| Powder for oral suspension equivalent to 250 mg amoxycillin per 5 mL, 100 mL |
| Powder for oral suspension equivalent to 500 mg amoxycillin per 5 mL, 100 mL |
Azithromycin Dihydrate with Water - Purified BP | Powder for oral suspension equivalent to 200 mg azithromycin per 5 mL, 15 mL |
Cefaclor Monohydrate with Water - | Powder for oral suspension equivalent to 125 mg cefaclor per 5 mL, 100 mL Powder for oral suspension equivalent to 250 mg cefaclor per 5 mL, 75 mL |
Cephalexin with Water - Purified BP | Granules for oral suspension 125 mg per 5 mL, 100 mL |
| Granules for oral suspension 250 mg per 5 mL, 100 mL |
Erythromycin Ethyl Succinate with Water - Purified BP | Powder for oral liquid equivalent to 200 mg erythromycin per 5 mL, 100 mL |
| Powder for oral liquid equivalent to 400 mg erythromycin per 5 mL, 100 mL |
Flucloxacillin Magnesium with Water - Purified BP | Powder for oral suspension equivalent to 125 mg flucloxacillin per 5 mL, 100 mL |
| Powder for oral suspension equivalent to 250 mg flucloxacillin per 5 mL, 100 mL |
Mycophenolate Mofetil with Water - | Powder for oral suspension 1 g per 5 mL, 165 mL |
| |
SCHEDULE 2 — LIST OF DRUGS THAT ARE USED IN THE PREPARATION OF EXTEMPORANEOUSLY-PREPARED PHARMACEUTICAL BENEFITS AND THAT ARE UNSTABLE OR PACKED STERILE AND UNUSED QUANTITIES OF WHICH ARE UNSUITABLE FOR FUTURE USE
Water for Injections - sterilised BP
|
Buprenorphine | Transdermal patch 5 mg | |
| Transdermal patch 10 mg | |
| Transdermal patch 20 mg | |
Codeine Phosphate | Tablet 30 mg | |
Dexamphetamine Sulfate | Tablet 5 mg | |
Fentanyl | Transdermal patch 2.1 mg | |
| Transdermal patch 4.2 mg | |
| Transdermal patch 8.4 mg | |
| Transdermal patch 12.6 mg | |
| Transdermal patch 16.8 mg | |
Hydromorphone Hydrochloride | Tablet 2 mg | |
| Tablet 4 mg | |
| Tablet 8 mg | |
| Oral liquid 1 mg per mL, 473 mL | |
| Injection 2 mg in 1 mL ampoule | |
| Injection 10 mg in 1 mL ampoule | |
| Injection 50 mg in 5 mL ampoule | |
| Injection 500 mg in 50 mL vial | |
Methadone Hydrochloride | Tablet 10 mg | |
| Oral liquid 25 mg per 5 mL, 200 mL | |
| Injection 10 mg in 1 mL ampoule | |
Methylphenidate Hydrochloride | Tablet 10 mg | |
Morphine Hydrochloride | Oral solution 2 mg per mL, 200 mL | |
| Oral solution 5 mg per mL, 200 mL | |
| Oral solution 10 mg per mL, 200 mL | |
Morphine Sulfate | Tablet 10 mg | |
| Tablet 20 mg | |
| Tablet 30 mg | |
| Tablet 5 mg (controlled release) | |
| Tablet 10 mg (controlled release) | |
| Tablet 15 mg (controlled release) | |
| Tablet 30 mg (controlled release) | |
| Tablet 60 mg (controlled release) | |
| Tablet 100 mg (controlled release) | |
| Tablet 200 mg (controlled release) | |
| Capsule 10 mg (containing sustained release pellets) | |
| Capsule 20 mg (containing sustained release pellets) | |
| Capsule 30 mg (controlled release) | |
| Capsule 50 mg (containing sustained release pellets) | |
| Capsule 60 mg (controlled release) | |
| Capsule 90 mg (controlled release) | |
| Capsule 100 mg (containing sustained release pellets) | |
| Capsule 120 mg (controlled release) | |
| Sachet containing controlled release granules for oral suspension, 20 mg per sachet | |
| Sachet containing controlled release granules for oral suspension, 30 mg per sachet | |
| Sachet containing controlled release granules for oral suspension, 60 mg per sachet | |
| Sachet containing controlled release granules for oral suspension, 100 mg per sachet | |
| Sachet containing controlled release granules for oral suspension, 200 mg per sachet | |
| Injection 10 mg in 1 mL ampoule | |
| Injection 15 mg in 1 mL ampoule | |
| Injection 30 mg in 1 mL ampoule | |
Morphine Tartrate | Injection 120 mg in 1.5 mL ampoule | |
Oxycodone Hydrochloride | Tablet 5 mg | |
| Capsule 5 mg | |
| Capsule 10 mg | |
| Capsule 20 mg | |
| Oral solution 5 mg per 5 mL, 250 mL | |
| Tablet 5 mg (controlled release) | |
| Tablet 10 mg (controlled release) | |
| Tablet 20 mg (controlled release) | |
| Tablet 40 mg (controlled release) | |
| Tablet 80 mg (controlled release) | |
Oxycodone Pectinate | Suppository equivalent to 30 mg oxycodone | |
Pethidine Hydrochloride | Injection 100 mg in 2 mL ampoule | |
| ||
Aciclovir | Eye ointment 30 mg per g, 4.5 g |
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP | Powder for oral suspension equivalent to 125 mg amoxycillin-31.25 mg clavulanic acid per 5 mL, 75 mL |
| Powder for oral suspension equivalent to 400 mg amoxycillin-57 mg clavulanic acid per 5 mL, 60 mL |
Amoxycillin Trihydrate with Water - Purified BP | Powder for paediatric oral drops equivalent to 100 mg amoxycillin per mL, 20 mL |
| Powder for oral suspension equivalent to 125 mg amoxycillin per 5 mL, 100 mL |
| Powder for oral suspension equivalent to 250 mg amoxycillin per 5 mL, 100 mL |
| Powder for oral suspension equivalent to 500 mg amoxycillin per 5 mL, 100 mL |
Apraclonidine Hydrochloride | Eye drops equivalent to 5 mg apraclonidine per mL, 10 mL |
Aprepitant | Pack containing 1 capsule 125 mg and 2 capsules 80 mg |
Atovaquone | Oral suspension 750 mg per 5 mL, 210 mL |
Atropine Sulfate | Eye drops 10 mg per mL, 15 mL |
Azithromycin Dihydrate with Water - Purified BP | Powder for oral suspension equivalent to 200 mg azithromycin per 5 mL, 15 mL |
Beclomethasone Dipropionate | Pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation) |
| Pressurised inhalation 100 micrograms per dose, 200 doses (CFC-free formulation) |
| Pressurised inhalation in breath actuated device 50 micrograms per dose, 200 doses (CFC-free formulation) |
| Pressurised inhalation in breath actuated device 100 micrograms per dose, 200 doses (CFC-free formulation) |
Benzydamine Hydrochloride | Mouth and throat rinse 22.5 mg per 15 mL, 500 mL |
Betamethasone Dipropionate | Cream equivalent to 500 micrograms betamethasone per g, 15 g |
| Ointment equivalent to 500 micrograms betamethasone per g, 15 g |
Betamethasone Valerate | Cream equivalent to 500 micrograms betamethasone per g, 15 g |
| Ointment equivalent to 500 micrograms betamethasone per g, 15 g |
Betaxolol Hydrochloride | Eye drops, suspension, equivalent to 2.5 mg betaxolol per mL, 5 mL |
| Eye drops, solution, equivalent to 5 mg betaxolol per mL, 5 mL |
Bimatoprost | Eye drops 300 micrograms per mL, 3 mL |
Bisacodyl | Enemas 10 mg in 5 mL, 25 |
Brimonidine Tartrate | Eye drops 2 mg per mL, 5 mL |
Brimonidine Tartrate with Timolol Maleate | Eye drops 2 mg brimonidine tartrate with timolol maleate equivalent to 5 mg timolol per mL, 5 mL |
Brinzolamide | Eye drops 10 mg per mL, 5 mL |
Budesonide | Nebuliser suspension 500 micrograms in 2 mL single dose units, 30 |
| Nebuliser suspension 1 mg in 2 mL single dose units, 30 |
| Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses |
| Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses |
| Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses |
Budesonide with Eformoterol Fumarate Dihydrate | Powder for oral inhalation in breath actuated device 100 micrograms-6 micrograms per dose, 120 doses |
| Powder for oral inhalation in breath actuated device 200 micrograms-6 micrograms per dose, 120 doses |
Calcipotriol | Ointment 50 micrograms per g, 30 g |
Captopril | Oral solution 5 mg per mL, 95 mL |
Carbamazepine | Oral suspension 100 mg per 5 mL, 300 mL |
Carbomer 980 | Ocular lubricating gel 2 mg per g, 10 g |
Carmellose Sodium | Eye drops 5 mg per mL, 15 mL |
| Eye drops 10 mg per mL, 15 mL |
| Mouth spray 10 mg per mL, 25 mL |
| Mouth spray 10 mg per mL, 100 mL |
Carmustine | Implants 7.7 mg, 8 |
Cefaclor Monohydrate with Water - | Powder for oral suspension equivalent to 125 mg cefaclor per 5 mL, 100 mL Powder for oral suspension equivalent to 250 mg cefaclor per 5 mL, 75 mL |
Cephalexin with Water - Purified BP | Granules for oral suspension 125 mg per 5 mL, 100 mL |
| Granules for oral suspension 250 mg per 5 mL, 100 mL |
Chloramphenicol | Ear drops (aqueous) 5 mg per mL, 5 mL |
| Eye drops 5 mg per mL, 10 mL |
| Eye ointment 10 mg per g, 4 g |
Chlorpromazine Hydrochloride | Oral solution 25 mg per 5 mL, 100 mL |
Cholestyramine | Sachets containing 9.4 g oral powder (equivalent to 8 g cholestyramine), 50 |
Ciclesonide | Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation) |
| Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation) |
Ciprofloxacin Hydrochloride | Ear drops equivalent to 3 mg ciprofloxacin per mL, 5 mL |
Coal Tar - Prepared | Gel 10 mg per g, 100 mL |
Colestipol Hydrochloride | Oral powder, sachets 5 g, 120 |
Desmopressin Acetate | Nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL |
Dexamethasone | Eye drops 1 mg per mL, 5 mL |
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin | Ear drops 500 micrograms (dexamethasone)-5 mg-50 micrograms per mL, 8 mL |
Dipivefrine Hydrochloride | Eye drops 1 mg per mL, 10 mL |
Disodium Etidronate and Calcium Carbonate | Pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium) |
Dorzolamide Hydrochloride | Eye drops equivalent to 20 mg dorzolamide per mL, 5 mL |
Dorzolamide Hydrochloride with Timolol Maleate | Eye drops equivalent to 20 mg dorzolamide-5 mg timolol per mL, 5 mL |
Eformoterol Fumarate Dihydrate | Powder for oral inhalation in breath actuated device 6 micrograms per dose, 60 doses |
| Powder for oral inhalation in breath actuated device 12 micrograms per dose, 60 doses |
Erythromycin Ethyl Succinate with Water - Purified BP | Powder for oral liquid equivalent to 200 mg erythromycin per 5 mL, 100 mL |
| Powder for oral liquid equivalent to 400 mg erythromycin per 5 mL, 100 mL |
Escitalopram Oxalate | Oral solution equivalent to 10 mg escitalopram per mL, 28 mL |
Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate | Pack containing 14 tablets (enteric coated) esomeprazole magnesium trihydrate equivalent to 20 mg esomeprazole, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin trihydrate equivalent to 500 mg amoxycillin |
Ethosuximide | Oral solution 250 mg per 5 mL, 200 mL |
Ferrous Sulfate | Oral liquid 30 mg per mL, 250 mL |
Flucloxacillin Magnesium with Water - Purified BP | Powder for oral suspension equivalent to 125 mg flucloxacillin per 5 mL, 100 mL |
| Powder for oral suspension equivalent to 250 mg flucloxacillin per 5 mL, 100 mL |
Fluorometholone | Eye drops 1 mg per mL, 5 mL |
Fluorometholone Acetate | Eye drops 1 mg per mL, 5 mL |
Fluticasone Propionate | Pressurised inhalation 50 micrograms per dose, 120 doses (CFC-free formulation) |
| Pressurised inhalation 125 micrograms per dose, 120 doses (CFC-free formulation) |
| Pressurised inhalation 250 micrograms per dose, 120 doses (CFC-free formulation) |
| Powder for oral inhalation in breath actuated device 100 micrograms per dose, 60 doses |
| Powder for oral inhalation in breath actuated device 250 micrograms per dose, 60 doses |
| Powder for oral inhalation in breath actuated device 500 micrograms per dose, 60 doses |
Fluticasone Propionate with Salmeterol Xinafoate | Pressurised inhalation 50 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation) |
| Pressurised inhalation 125 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation) |
| Pressurised inhalation 250 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation) |
| Powder for oral inhalation in breath actuated device 100 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses |
| Powder for oral inhalation in breath actuated device 250 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses |
| Powder for oral inhalation in breath actuated device 500 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses |
Framycetin Sulfate | Eye or ear drops 5 mg per mL, 8 mL |
Frusemide | Oral solution 10 mg per mL, 30 mL |
Gentamicin Sulfate | Eye drops equivalent to 3 mg gentamicin per mL, 5 mL |
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate | Oral rehydration salts 3.56 g-470 mg-300 mg-530 mg per sachet, 10 |
Glucose Indicator—Blood | Electrode strips, 100 (Optium glucose) |
| Electrode strips, 100 (Precision Plus) |
| Electrode strips, 100 (SofTact) |
| Electrode strips, 100 (TrueSense) |
Glyceryl Trinitrate | Tablets 600 micrograms, 100 |
| Buccal/sublingual spray (pump pack) 400 micrograms per dose, 200 doses |
Haloperidol | Oral solution 2 mg per mL, 100 mL |
Homatropine Hydrobromide | Eye drops 20 mg per mL, 15 mL |
Hydrocortisone | Cream 10 mg per g, 50 g |
Hydrocortisone Acetate | Eye ointment 5 mg per g, 5 g |
| Eye ointment 10 mg per g, 5 g |
| Cream 10 mg per g, 30 g |
| Cream 10 mg per g, 50 g |
| Ointment 10 mg per g, 30 g |
| Ointment 10 mg per g, 50 g |
Hypromellose | Eye drops 3 mg per mL, 15 mL |
| Eye drops 5 mg per mL, 15 mL |
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg-2 mg per g, 10 g |
Hypromellose 4500 with Dextran 70 | Eye drops 3 mg-1 mg per mL, 15 mL |
Ketoconazole | Cream 20 mg per g, 30 g |
| Shampoo 10 mg per g, 100 mL |
| Shampoo 20 mg per g, 60 mL |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL |
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL |
Latanoprost with Timolol Maleate | Eye drops 50 micrograms latanoprost with timolol maleate equivalent to 5 mg timolol per mL, 2.5 mL |
Leflunomide | Pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg |
Levobunolol Hydrochloride | Eye drops 2.5 mg per mL, 5 mL |
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride | Sachets containing powder for oral solution 13.125 g-350.7 mg-178.5 mg-46.6 mg, 30 |
Mesalazine | Suppositories 1 g, 28 |
"Metabolic Mineral Mixture" | Oral powder 250 g |
Methylprednisolone Aceponate | Cream 1 mg per g, 15 g |
| Ointment 1 mg per g, 15 g |
| Fatty ointment 1 mg per g, 15 g |
| Lotion 1 mg per g, 20 g |
Metoclopramide Hydrochloride | Oral solution 5 mg per 5 mL, 100 mL |
Metoprolol Succinate | Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release) |
Metronidazole | Suppositories 500 mg, 10 |
Metronidazole Benzoate | Oral suspension 320 mg per 5 mL, 100 mL |
Miconazole | Tincture 20 mg per mL, 30 mL |
Miconazole Nitrate | Cream 20 mg per g, 30 g |
| Cream 20 mg per g, 70 g |
| Powder 20 mg per g, 30 g |
| Lotion 20 mg per mL, 30 g |
Mometasone Furoate | Cream 1 mg per g, 15 g |
| Ointment 1 mg per g, 15 g |
| Lotion 1 mg per g, 30 mL |
Mycophenolate Mofetil with Water - | Powder for oral suspension 1 g per 5 mL, 165 mL |
Nafarelin Acetate | Nasal spray (pump pack) equivalent to 200 micrograms nafarelin per dose, 60 doses |
Naproxen | Oral suspension 125 mg per 5 mL, 474 mL |
Nedocromil Sodium | Pressurised inhalation 2 mg per dose, 112 doses (CFC-free formulation) |
Neomycin Undecenoate with Bacitracin Zinc | Ear ointment 12 mg (3.5 mg neomycin)-400 units per g, 10 g |
Nicorandil | Tablets 10 mg, 60 |
| Tablets 20 mg, 60 |
Nystatin | Oral suspension 100,000 units per mL, 24 mL |
Oestradiol | Transdermal patches 390 micrograms, 8 |
| Transdermal patches 2 mg, 4 |
| Transdermal patches 2 mg, 8 |
| Transdermal patches 585 micrograms, 8 |
| Transdermal patches 3.28 mg, 8 |
| Transdermal patches 3.8 mg, 4 |
| Transdermal patches 4 mg, 8 |
| Transdermal patches 780 micrograms, 8 |
| Transdermal patches 4.33 mg, 8 |
| Transdermal patches 5.7 mg, 4 |
| Transdermal patches 1.17 mg, 8 |
| Transdermal patches 6.57 mg, 8 |
| Transdermal patches 7.6 mg, 4 |
| Transdermal patches 8 mg, 8 |
| Transdermal patches 1.56 mg, 8 |
| Transdermal patches 8.66 mg, 8 |
| Vaginal tablets 25 micrograms, 15 |
Oestradiol and Oestradiol with Dydrogesterone | Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg |
Oestradiol and Oestradiol with Norethisterone Acetate | Pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg |
| Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg |
Oestradiol Hemihydrate | Nasal spray 150 micrograms per actuation, 60 actuations, 4.2 mL |
| Transdermal gel equivalent to 1 mg oestradiol in 1 g sachet, 28 |
| Transdermal patches equivalent to 750 micrograms oestradiol, 8 |
| Transdermal patches equivalent to 1.5 mg oestradiol, 8 |
| Transdermal patches equivalent to 3 mg oestradiol, 8 |
Oestradiol Hemihydrate and Oestradiol Hemihydrate with Norethisterone Acetate | Pack containing 4 transdermal patches equivalent to 4.33 mg oestradiol and 4 transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate |
| Pack containing 4 transdermal patches equivalent to 4.33 mg oestradiol and 4 transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate |
Oestradiol Hemihydrate with Norethisterone Acetate | Tablets equivalent to 1 mg oestradiol with 500 micrograms norethisterone acetate, 28 |
| Tablets equivalent to 2 mg oestradiol with 1 mg norethisterone acetate, 28 |
| Transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate, 8 |
| Transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate, 8 |
Oestriol | Pessaries 500 micrograms, 15 |
| Vaginal cream 1 mg per g, 15 g |
Oestrogens—Conjugated with Medroxyprogesterone Acetate | Tablets 625 micrograms-2.5 mg, 28 Tablets 625 micrograms-5 mg, 28 |
Omeprazole and Clarithromycin and Amoxycillin Trihydrate | Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin trihydrate equivalent to 500 mg amoxycillin |
Ondansetron Hydrochloride Dihydrate | Syrup equivalent to 4 mg ondansetron per 5 mL, 50 mL |
Paracetamol | Oral liquid 120 mg per 5 mL, 100 mL |
| Oral liquid 240 mg per 5 mL, 200 mL |
| Suppositories 500 mg, 24 |
Paraffin - Soft White with Paraffin - Liquid | Pack containing 2 tubes eye ointment, compound, 3.5 g |
Permethrin | Cream 50 mg per g, 30 g |
Phenytoin | Oral suspension 30 mg per 5 mL, 500 mL |
Pilocarpine Hydrochloride | Eye drops 5 mg per mL, 15 mL |
| Eye drops 10 mg per mL, 15 mL |
| Eye drops 20 mg per mL, 15 mL |
| Eye drops 40 mg per mL, 15 mL |
| Eye drops 60 mg per mL, 15 mL |
Pimecrolimus | Cream 10 mg per g, 15 g |
Polyethylene Glycol 400 with Propylene Glycol | Eye drops 4 mg-3 mg per mL, 15 mL |
Polyvinyl Alcohol | Eye drops 14 mg per mL, 15 mL |
| Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) |
| Eye drops 30 mg per mL, 15 mL |
| Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) |
Prednisolone Acetate with Phenylephrine Hydrochloride | Eye drops 10 mg-1.2 mg per mL, 10 mL |
Prednisolone Sodium Phosphate | Oral solution equivalent to 5 mg prednisolone per mL, 30 mL |
Prochlorperazine | Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5 |
| Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5 |
Promethazine Hydrochloride | Oral liquid 5 mg per 5 mL, 100 mL |
Quinagolide Hydrochloride | Pack containing 3 tablets equivalent to 25 micrograms quinagolide and 3 tablets equivalent to 50 micrograms quinagolide |
Ramipril | Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg |
Reteplase | Pack containing 2 vials powder for injection 10 units, 2 single use pre-filled syringes with solvent, 2 reconstitution spikes and 2 needles |
Rifampicin | Syrup 100 mg per 5 mL, 60 mL |
Risedronate Sodium and Calcium Carbonate | Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium) |
Risperidone | Oral solution 1 mg per mL, 30 mL |
| Oral solution 1 mg per mL, 100 mL |
Rivastigmine Hydrogen Tartrate | Oral solution equivalent to 2 mg rivastigmine per mL, 120 mL |
Salbutamol Sulfate | Nebuliser solution equivalent to 2.5 mg salbutamol in 2.5 mL single dose units, 30 |
| Pressurised inhalation equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation) |
| Nebuliser solution equivalent to 5 mg salbutamol in 2.5 mL single dose units, 30 |
Salmeterol Xinafoate | Pressurised inhalation equivalent to 25 micrograms salmeterol per dose, 120 doses |
| Powder for oral inhalation in breath actuated device equivalent to 50 micrograms salmeterol per dose, 60 doses |
Silver Sulfadiazine with Chlorhexidine Gluconate | Cream 10 mg-2 mg per g, 50 g Cream 10 mg-2 mg per g, 100 g |
Sirolimus | Oral solution 1 mg per mL, 60 mL |
Sodium Cromoglycate | Pressurised inhalation 1 mg per dose, 200 doses |
| Pressurised inhalation 1 mg per dose, 200 doses (CFC-free formulation) |
| Pressurised inhalation 5 mg per dose, 112 doses (CFC-free formulation) |
| Eye drops 20 mg per mL, 10 mL |
Sterculia with Frangula Bark | Granules 620 mg-80 mg per g, 500 g |
Sulfacetamide Sodium | Eye drops 100 mg per mL, 15 mL |
Terbutaline Sulfate | Powder for oral inhalation in breath actuated device 500 micrograms per dose, 200 doses
|
Testosterone | Transdermal gel 50 mg in 5 g sachet, 30 |
| Transdermal patches 12.2 mg, 60 |
| Transdermal patches 24.3 mg, 30 |
Theophylline | Oral solution 133.3 mg per 25 mL, 500 mL |
Timolol Maleate | Eye gel equivalent to 1 mg timolol per g, 5 g |
| Eye drops equivalent to 2.5 mg timolol per mL, 5 mL |
| Eye drops equivalent to 5 mg timolol per mL, 5 mL |
| Eye drops (gellan gum solution) equivalent to 2.5 mg timolol per mL, 2.5 mL |
| Eye drops (gellan gum solution) equivalent to 5 mg timolol per mL, 2.5 mL |
Tobramycin | Eye drops 3 mg per mL, 5 mL |
| Eye ointment 3 mg per g, 3.5 g |
Tramadol Hydrochloride | Oral drops 100 mg per mL, 10 mL |
Travoprost | Eye drops 40 micrograms per mL, 2.5 mL |
Travoprost with Timolol Maleate | Eye drops 40 micrograms travoprost with timolol maleate equivalent to 5 mg timolol per mL, 2.5 mL |
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin | Ear drops 1 mg-2.5 mg (neomycin)-250 micrograms-100,000 units per g, 7.5 mL |
| Ear ointment 1 mg-2.5 mg (neomycin)-250 micrograms-100,000 units per g, 5 g |
Trimethoprim with Sulfamethoxazole | Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL |
| |
Creams Salicylic Acid and Sulfur Aqueous APF
Dusting Powders Zinc, Starch and Talc APF 15
Zinc, Starch and Talc BPC 1973
Ear Drops Aluminium Acetate APF
Aluminium Acetate BP
Sodium Bicarbonate APF
Sodium Bicarbonate BP
Spirit APF
Eye Drops containing Cocaine Hydrochloride BP —
Eye Drops, Other —
Eye Lotions —
Inhalations Benzoin and Menthol APF
Menthol APF
Menthol and Eucalyptus BP 1980
Linctuses containing Codeine Phosphate BP Codeine APF
Linctuses, Other —
Lotions Aluminium Acetate Aqueous APF
Mixtures containing Codeine Phosphate BP —
Mixtures, Other Gentian Alkaline APF
Kaolin BPC 1968
Kaolin and Opium APF 14
Magnesium Trisilicate BPC 1968
Magnesium Trisilicate and Belladonna BPC 1968
Mixtures for Children containing Codeine Phosphate BP —
Mixtures for Children, Other —
Mouth Washes Thymol Compound APF 15
Nasal Instillations —
Ointments Benzoic Acid Compound APF
Benzoic Acid Compound (extemporaneous formula) BP
Boric Acid, Olive Oil and Zinc Oxide QHF
Salicylic Acid APF
Salicylic Acid (extemporaneous formula) BP
Paints Podophyllin Compound APF 16
Podophyllin Compound BP
Salicylic Acid APF
Pastes containing Cocaine Hydrochloride BP —
Pastes, Other Zinc APF
Zinc Compound (extemporaneous formula) BP
Powders for Internal Use Magnesium Trisilicate BP
Solutions —
|
Notes to the Determination under paragraph 98C (1) (b) (No. PB 50 of 2006)
Note 1
The Determination under paragraph 98C (1) (b) (No. PB 50 of 2006) (in force under paragraph 98C (1) (b) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.
Table of Instruments
Title | Date of FRLI Registration | Date of | Application, saving or |
No. PB 50 of 2006 | 14 Nov 2006 (see F2006L03689) | 1 Dec 2006 |
|
No. PB 9 of 2007 | 11 Jan 2007 (see F2007L00080) | 1 Feb 2007 | — |
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
Provision affected | How affected |
Schedule 4 |
|
Schedule 4............ | am. No. PB 9 of 2007 |