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| Ingredient | ATC Level 1 | ATC Level 2 | Year Of Switch | Country | Status | Additional Information |
|---|---|---|---|---|---|---|
| Fluoride (sodium) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A01. Stomatological preparations | — | Australia | OTC | Effective September 2008: - max. 15mg/kg fluoride ion provided general exemption from scheduling - reduce the Schedule 4 (prescription) to Schedule 2 (pharmacy only) cut-off for preparations for ingestion (i.e. fluoride supplements) to max. 0.5mg fluoride ion per dosage unit - liquid preparations for topical use in Schedule 4 unless: (i) exempt from scheduling: max. 220mg/kg, in packs containing max. 120mg total fluoride when fitted with a child-resistant closure (CRC) and labelled: (a) according to the RASML when for therapeutic use, or (b) with warning statements to the effect of "Do not swallow" and "Do not use in children 6 years of age or less" when for non therapeutic use. (ii) Schedule 2: max. 1000mg/kg, fitted with a CRC and labelled as above. (iii) Schedule 3: max. 5500mg/kg, fitted with a CRC, which will be Schedule 3 (pharmacist only). - non-liquid preparations for topical use in Schedule 4 unless: (i) exempt from scheduling: max. 1000mg/kg. (ii) exempt from scheduling: when not in a therapeutic product and containing more than 1000mg/kg and max. 1500mg/kg, when labelled according to the RASML when for therapeutic use, or with warning statements to the effect of "Do not swallow" and "Do not use in children 6 years of age or less". (iii) Schedule 3: max. 5500mg/kg. The schedule entries now read: S2: FLUORIDES for human use: (a) in preparations for ingestion containing 0.5mg or less of fluoride ion per dosage unit; or (b) in liquid preparations for topical use containing 1000mg/kg or less of fluoride ion, in a container with a child-resistant closure: (i) for therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels except in preparations containing 220mg/kg or less of fluoride ion, in packs containing not more than 120mg total fluoride when fitted with a child-resistant closure and compliant with the requirements of Required Advisory Statements for Medicine Labels. (ii) for non-therapeutic use when labelled with warnings to the following effect: (A) Do not swallow; and (B) Do not use [this product/name of product] in children six years of age or less, except in preparations containing 220mg/kg or less of fluoride ion, in packs containing not more than 120mg total fluoride, when fitted with a child-resistant closure and labelled with warnings to the following effect: (A) Do not swallow; and (B) Do not use [this product/name of product] in children six years of age or less, except in preparations containing 15mg/kg or less of fluoride ion or preparations for supply to registered dental professionals or by approval of an appropriate authority. S3: FLUORIDES for human topical use: (a) in liquid preparations containing 5500mg/kg or less of fluoride ion, in a container with a child-resistant closure except when included in or expressly excluded from Schedule 2; or (b) in non-liquid preparations containing 5500mg/kg or less of fluoride ion except: (i) in preparations for therapeutic use containing 1500mg/kg or less of fluoride ion and, when containing more than 1000mg/kg fluoride ion, compliant with the requirements of the Required Advisory Statements for Medicine Labels; (ii) in preparations for non-therapeutic use containing 1500mg/kg or less of fluoride ion and, when containing more than 1000mg/kg fluoride ion, labelled with warnings to the following effect: (A) Do not swallow; and (B) Do not use [this product/name of product] in children six years of age or less; or (iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority. S4: FLUORIDES in preparations for human use except when included in or expressly excluded from Schedule 2 or 3. |
| Hexetidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A01. Stomatological preparations | — | Australia | Rx | — |
| Aluminium hydroxide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Australia | OTC | General sale. |
| Calcium carbonate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Australia | OTC | General sale. |
| Carbenoxolone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Australia | Rx | — |
| Cetraxate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Australia | N.R. | Not registered or not marketed. |
| Cimetidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1995 | Australia | OTC | Switched from S4 (prescription) to S3 (pharmacist only, advertising not allowed) in July 1995 for the relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 22 June 1997, dosage restriction and divided preparation controls removed (i.e. as the only therapeutically active substance in preparations for oral use for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply). Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in a primary pack containing not more than 14 days supply. Effective 1 January 2006, the indication "for the relief of symptoms of gastro-oesophageal reflux" was deleted from the S3 entry, i.e. "in a primary pack containing no more than 14 days' supply". |
| Famotidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1995 | Australia | OTC | Switched from S4 (prescription) to S3 (pharmacist only) in 1995 as the only therapeutically active substance in divided preparations for oral use containing 200mg or less of famotidine per dosage unit, for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 22 June 1997, dosage restriction and divided preparation controls removed i.e. as the only therapeutically active substance in preparations for oral use for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply. Switched to S2 (pharmacy only) effective 1 June 2001 'for the relief of symptoms of gastro-oesophageal reflux in packs containing not more than 14 days' supply'. Effective 1 January 2006, the indication 'for the relief of symptoms of gastro-oesophageal reflux' was deleted from the S2 entry, i.e. 'when sold in the manufacturer's original pack containing not more than 14 days' supply.' |
| Lansoprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | Australia | OTC | S4 (prescription) to S3 (pharmacist only) on 1 September 2010 in oral preparations containing 15mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply. In 2016, approval of Appendix H entry for Lansoprazole, allowing direct-to-consumer advertising. |
| Nizatidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1995 | Australia | OTC | S4 (prescription) until July 1995. As the only therapeutically active substance in divided preparations for oral use containing 200mg or less of nizatidine per dosage unit, for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 22 June 1997, dosage restriction and divided preparation controls removed i.e. as the only therapeutically active substance in preparations for oral use for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply. S3 (pharmacist only) to S2 (pharmacy only) switch, effective 1 March 2002 'for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days' supply.' Effective 1 January 2006, the indication 'for the relief of symptoms of gastro-oesophageal reflux' was deleted from the S2 entry, i.e. 'when sold in the manufacturer's original pack containing not more than 14 days supply'. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | Australia | OTC | S4 (prescription) to S3 (pharmacist only) on 1 September 2010 in oral preparations containing 20mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply. Effective 1 February 2016, approval of Appendix H entry for Omeprazole, allowing direct-to-consumer advertising. Effective 1 June 2016, S3 to S2 switch for omeprazole in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days’ supply. Other entries in S3 and S4 |
| Pantoprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2008 | Australia | OTC | Pantoprazole was switched on 1 May 2008 from prescription-only to S3 status (pharmacist only) in oral preparations containing 20mg or less for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply. The product cannot be advertised to the general public. 2015: A new Schedule 2 (pharmacy only) entry was approved for Pantoprazole - in oral preparations containing 20mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7days’ supply. Effective 1 June 2015, approval of a new Appendix H entry for pantoprazole, allowing direct-to-consumer advertising. |
| Rabeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | Australia | OTC | Rabeprazole 10mg was switched from prescription-only to non-prescription S3 (pharmacist only) status with effect from 1 January 2010 in oral preparations containing 10mg or less of rabeprazole for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease in packs containing not more than 14 days of supply. Effective 1 February 2016, approval of a new Appendix H entry for Rabeprazole, allowing direct-to-consumer advertising. Effective 1 June 2016, S3 to S2 switch for rabeprazole in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days’ supply. |
| Ranitidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1995 | Australia | OTC | S3 (pharmacist only) as the only therapeutically active substance in preparations for oral use for the relief of symptoms of gastro-oesophageal reflux in packs containing not more than 14 days supply (Rx to S3 in stages (1995-1997)). Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply. S3 to S2 (pharmacy only) switch, effective 1 June 2001 'for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days' supply.' Effective 1 January 2006, the indication "for the relief of symptoms of gastro-oesophageal reflux" was deleted from the S2 entry, i.e. 'when sold in the manufacturer's original pack containing not more than 14 days' supply.' Effective 1 September 2007, switch to General Sale (GSL) for ranitidine in packs of less than 14 dosage units. "Ranitidine in preparations supplied in the manufacturer's original pack containing not more than 14 days' supply except in divided preparations for oral use containing 150mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 14 dosage units." Effective 1 October 2015, approval of switch to General Sale (GSL) for ranitidine in divided preparations for oral use containing 300mg or less of ranitidine per dosage unit (in the manufacturer’s original pack) containing not more than 7 dosage units. |
| Sucralfate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1982 | Australia | OTC | General sale. |
| Dicyclomine (Dicycloverine) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | Australia | Rx | S2 (pharmacy only) entry deleted and rescheduled to S4 (prescription) effective 1 May 2007. |
| Dimeticone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | Australia | OTC | General sale. Spelt 'dimethicone' in Australia. |
| Domperidone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | Australia | Rx | — |
| Hyoscine butylbromide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | 1995 | Australia | OTC | June 1995, S4 (prescription) to S3 (pharmacist only) switch as the only therapeutically active substance in divided preparations for oral use containing 10mg or less of hyoscine butylbromide per dosage unit in a pack containing maximum 20 dosage units. 18 March 1999, switched to S2 (pharmacy only). Effective February 2003, S2 entry amended to increase dosage per unit from 10mg to 20mg or less of hyoscine butylbromide, and the pack size from 20 or less dosage units to 200mg or less of hyoscine butylbromide. |
| Mebeverine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | Australia | Rx | — |
| Metoclopramide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | 2000 | Australia | OTC | Effective March 2000, switched to S3 (pharmacist only) when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units. Advertising to the general public is not permitted. |
| Propantheline | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | Australia | Rx | Effective 1 May 2005, rescheduled from S2 (pharmacy only) to S4 (prescription) status (S2 entry deleted). |
| Dimenhydrinate (diphenhydramine and 8-chlorotheophylline) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A04. Antiemetics and antinauseants | — | Australia | OTC | S2 (pharmacy only) in primary packs of up to 10 doses for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age (S4). S3 (pharmacist only) in oral preparations except when included in S2 (e.g. larger primary pack). S3 preparations may be advertised ONLY if indicated for the prevention and relief of motion sickness. |
| Hyoscine (Scopolamine) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A04. Antiemetics and antinauseants | — | Australia | OTC | Up to 1 June 2002, preparations containing max 0.25% of hyoscine were sold as pharmacy medicines (S2). Effective 1 June 2002, only the following oral and transdermal preparations are permitted as S2. All others have been rescheduled to S4 (prescription medicines): (a) for transdermal use in preparations containing max 2mg of total solanaceous alkaloids per dosage unit, or (b) for oral use: (i) in undivided preparations containing max 0.03% of total solanaceous alkaloids when labelled with a dose of max 0.3mg of total solanaceous alkaloids and a recommended daily dose of max 1.2mg of solanaceous alkaloids, or (ii) in divided preparations containing max 0.3mg of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of max 1.2mg of total solanaceous alkaloids. |
| Hymecromone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A05. Bile and liver therapy | — | Australia | N.R. | Not registered or not marketed. |
| Bisacodyl | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | Australia | OTC | General sale. |
| Lactitol | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | Australia | N.R. | Not registered or not marketed. |
| Lactulose | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | Australia | OTC | General sale. |
| Macrogol (Polyethylene glycol 3350) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | 2000 | Australia | OTC | Effective 1 December 2000, Macrogol 3350 available as a Pharmacist-Only (S3) medicine for oral use for bowel cleansing purposes. The entry was amended effective 1 May 2007 to refer to 'Macrogol in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures'. No advertising to the general public is permitted. Macrogols when labelled for use as laxatives for the relief of constipation are available on General Sale (GSL). Effective 1 June 2014, new Schedule 2 (pharmacy only) entry for Macrogols in preparations for oral use as a liquid concentrate for laxative use. (All other macrogols, e.g. in powder form, when labelled for laxative use, remain GSL). |
| Picosulfate (sodium) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | Australia | OTC | Effective 1 September 2002, sodium picosulfate switched from GSL to S3 (pharmacist only) in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures. Advertising to the general public is not permitted. |
| Loperamide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents | 1987 | Australia | OTC | 1987: rescheduled from S4 (prescription) to S3 (pharmacist only) in packs of max 8 dosage units, each dosage unit containing max 2mg of loperamide. Switched in 1997 to S2 (pharmacy only) . In 2001, pack size increased to max 20 dosage units for oral use. Effective 1 May 2012, S2 to GSL switch for loperamide in small packs of up to 8 dosage units. |
| Nifuroxazide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents | — | Australia | N.R. | Not registered or not marketed. |
| Orlistat | A Alimentary tract and metabolism. Alimentary tract and metabolism | A08. Antiobesity preparations | 2004 | Australia | OTC | Effective 1 May 2004, S4 (prescription) to S3 (pharmacist only) switch for products containing max 120mg of orlistat per dosage unit. All other preparations remain S4. Effective 1 October 2007, Schedule H (S3 substances that may be advertised to the public) entry deleted, meaning consumer advertising no longer allowed. |
| Vitamin A (Retinol) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A11. Vitamins | — | Australia | OTC | General sale in preparations for topical use containing max 1% of vitamin A, in preparations for internal use containing max 3000 micrograms retinol equivalents of vitamin A per daily dose, or in preparations for parenteral nutrition replacement. |
| Selenium | A Alimentary tract and metabolism. Alimentary tract and metabolism | A12. Mineral supplements | — | Australia | OTC | S2 (pharmacy only) in preparations for human therapeutic use, except for topical use containing max 3.5% of selenium sulfide (GSL) or in preparations for oral use with a recommended daily dose of max 150 micrograms (GSL). Rx for human oral use with a recommended daily dose of more than 300 micrograms. |
| Tranexamic acid | B Blood and blood forming organs. Blood and blood forming organs | B02. Antihemorrhagics | — | Australia | Rx | S3 (pharmacist only) entry deleted and all preparations rescheduled to S4 (prescription) effective 1 September 2007. |
| Adenosine | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | — | Australia | Rx | Rx: in preparations for injection (Otherwise N.R.). |
| Nitro-glycerine | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | — | Australia | OTC | Known in Australia as Glyceryl trinitrate. S3 (pharmacist only) in preparations for oral use and in preparations for rectal use. All other preparations are S4 (prescription). Advertising to the general public is not permitted. |
| Ubidecarenone | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | — | Australia | OTC | General sale. |
| Lovastatin | C Cardiovascular system. Cardiovascular system | C10. Lipid modifying agents | — | Australia | N.R. | Not registered or not marketed. |
| Simvastatin | C Cardiovascular system. Cardiovascular system | C10. Lipid modifying agents | — | Australia | Rx | — |
| Amorolfine (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | OTC | March 1999, S4 (prescription) to S3 (pharmacist only) switch in topical preparations containing max 5% for the treatment of onychomycoses. March 2000, all amorolfine preparations for topical use switched from S4 to S3, except for preparations containing max 0.25%, which were switched from S4 to S2 (pharmacy only). September 2006, S2 to GSL switch for preparations for treatment of tinea pedis. September 2010, all amorolfine preparations for topical use switched from S3 to S2. S2 entry now reads "Amorolfine in preparations for topical use except in preparations for the treatment of tinea pedis." |
| Bifonazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1997 | Australia | OTC | Switched from S4 (prescription) to S2 (pharmacy only) in 1997 for human use in dermal preparations. Effective 1 March 2002, S2 to GSL for preparations containing max 1% of bifonazole for the treatment of the scalp. Effective 1 January 2006, dermal preparations switched from S2 to GSL for the treatment of tinea pedis. |
| Butenafine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Ciclopirox Olamine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 2001 | Australia | OTC | Effective 1 September 2001, ciclopirox included in S3 (pharmacist only) when in dermal preparations containing more than 1%, and in S2 (pharmacy only) when in preparations for dermal use containing max 1% of ciclopirox. S2: Ciclopirox in preparations for dermal use containing less than 2% of ciclopirox with effect from 1 September 2002. Indication for treatment of nails included in S2 entry from 1 January 2007. Effective 1 May 2007: GSL for preparations for the treatment of tinea pedis. Effective 1 September 2012, S2 entry amended to allow for preparations for application to the nails, containing max 8% of ciclopirox. S2 entry now reads: Ciclopirox - (a) in preparations for dermal use containing 2% or less of ciclopirox, except in preparations for the treatment of tinea pedis; or (b) in preparations for application to the nails containing 8% or less of ciclopirox. The S3 preparations cannot be advertised to the general public. |
| Clotrimazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1991 | Australia | OTC | In 1991, switched to S2 (pharmacy only) for human use in topical preparations containing max 1% of clotrimazole, for the treatment of fungal infections of the skin. In 1997, this was amended to all dermal preparations for human use. Effective 1 January 2006, switched from S2 to GSL status for dermal preparations in the treatment of tinea pedis. Indication for the treatment of nails included in S2 entry from 1 January 2007. |
| Croconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Econazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1994 | Australia | OTC | S2 (pharmacy only) in dermal preparations (Rx to S3 (pharmacist only) and S2 in stages (1994-1997)). Effective 1 January 2006, S2 to GSL switch in dermal preparations for the treatment of tinea pedis. |
| Fenticonazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Fluconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 2004 | Australia | OTC | No topical use, only oral use. |
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