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| Ingredient | ATC Level 1 | ATC Level 2 | Year Of Switch | Country | Status | Additional Information |
|---|---|---|---|---|---|---|
| Haloprogin (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Isoconazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | OTC | S2 (pharmacy only) in dermal preparations (Otherwise Rx). |
| Ketoconazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1994 | Australia | OTC | In 1994, ketoconazole was rescheduled to S3 (pharmacist only) for human use in topical preparations containing max 2% of ketoconazole, for the treatment of fungal infections of the skin. In 1997, it was rescheduled to S2 (pharmacy only) for human use in dermal preparations. In September 1999, preparations containing max 1% for the treatment of the scalp were exempted from scheduling (GSL). Effective 1 January 2006, dermal preparations for the treatment of tinea pedis were exempted from scheduling. |
| Miconazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1990 | Australia | OTC | Rescheduled from S3 (pharmacist only) to S2 (pharmacy only) in 1990 for human use in preparations containing max 2% of miconazole for the treatment of fungal infections of the skin. In June 1997, this entry was amended to apply to all dermal preparations for human use. In May 2006, the S2 entry was further amended to clarify that this schedule also covered miconazole application to the nails. Switched to S3 in 1994 in topical preparations for vaginal use and when containing max 2% of miconazole for the treatment of oral candidiasis. In June 1999, concentration limitation removed i.e. miconazole for human use in topical preparations for treatment of oral candidiasis, or for vaginal use. Effective 1 January 2006, S2 to GSL switch for dermal preparations for the treatment of tinea pedis. The S3 indications for miconazole, i.e. oral candidiasis and vaginal use, may be advertised to consumers. |
| Miconazole & Hydrocortisone (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1999 | Australia | OTC | In September 1999, preparations for dermal use containing hydrocortisone or hydrocortisone acetate 1% in packs of 30g or less with no other therapeutically active substance except an antifungal for dermal use were switched to S3 (pharmacist only). Preparations for dermal use containing 0.5% of hydrocortisone or hydrocortisone acetate in packs of 30g or less with no other therapeutically active substance except an antifungal were switched to S2 (pharmacy only). Note: hydrocortisone, clotrimazole, econazole, miconazole, fluconazole and nystatin can be advertised to consumers. Effective 1 February 2016, new Schedule 2 entry for hydrocortisone 1% in combination with an antifungal, for dermal use in preparations containing 1% or less of hydrocortisone, in packs containing 15g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent: i) for the treatment of tinea (tinea pedis, tinea cruis, tinea corporis) and other fungal skin infections; and ii) not labelled for the treatment of children under 12 years of age. |
| Naftifine (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Natamycin (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | Rx | — |
| Neticonazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | — | No information. |
| Nystatin | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1990 | Australia | OTC | Rescheduled to S3 (pharmacist only) in 1990 in treatments for topical use for treatment of candidal infections only. In March 1997, the S3 entry was amended to 'preparations for topical use', and preparations for dermal use rescheduled to S2 (pharmacy only). Nystatin preparations in S3 (topical use) may be advertised to consumers. |
| Oxiconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 2006 | Australia | OTC | Effective 1 January 2006, S4 (prescription) to GSL switch for dermal preparations for the treatment of tinea pedis. Effective 1 September 2006, S4 to S3 (pharmacist only) switch for vaginal use and S4 to S2 switch for dermal preparations. Oxiconazole preparations for vaginal use cannot be advertised to consumers. |
| Selenium sulphide | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | OTC | General sale in preparations for topical therapeutic use containing max 2.5% of selenium sulfide. Effective 1 January 2004, S4 (prescription) to S2 (pharmacy only) switch for topical preparations for human topical therapeutic use except in preparations containing max 3.5% of selenium sulfide (which are GSL). S4 to GSL for preparations containing between 2.5% and 3.5% of selenium sulphide. |
| Sulconazole nitrate (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Terbinafine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1996 | Australia | OTC | Effective December 1996, switched from S4 (prescription) to S2 (pharmacy only) in topical preparations containing max 1% of terbinafine, for the treatment of fungal infections of the skin. Effective June 1999, limit on concentration removed. S2 in preparations for dermal use. Effective May 2007, switch from S2 to GSL for preparations for tinea pedis. |
| Tioconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1987 | Australia | OTC | In 1987, rescheduled from S4 (prescription) to S3 (pharmacist only) for human use in preparations containing max 1% of tioconazole, for the treatment of fungal infections of the skin. Effective June 1999, S4 to S3 in preparations for vaginal use, and S3 to S2 (pharmacy only) switch in all preparations for dermal use, i.e. no strength limitation. Effective 1 January 2006, S2 to GSL switch for dermal preparations for the treatment of tinea pedis. The S3 indication for vaginal use cannot be advertised to consumers. |
| Tolnaftate | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | Australia | OTC | General sale. |
| Hyaluronic acid (topical) | D Dermatologicals. Dermatologicals | D03. Preparations for treatment of wounds and ulcers | — | Australia | OTC | General sale. |
| Calcipotriol | D Dermatologicals. Dermatologicals | D05. Antipsoriatics | — | Australia | Rx | — |
| Aciclovir (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | 1996 | Australia | OTC | Effective December 1996, switched from S4 (prescription) to S2 (pharmacy only) in preparations containing max 5% of aciclovir for external use for the treatment of herpes labialis in packs containing max 10g. Effective June 2002, these preparations were switched to general sale (i.e., S2 entry deleted). All other aciclovir preparations are scheduled S4. Effective 1 October 2015, new Schedule 3 (pharmacist only) entry - hydrocortisone in combination with aciclovir for dermal use, in packs containing 2g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) for use in adults and adolescents (12 years of age and older). |
| Chlortetracycline (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | Australia | Rx | — |
| Docosanol (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Famciclovir | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | 2012 | Australia | OTC | Effective 1 May 2012, Famciclovir for oral use, in divided preparations, containing a total dose of 1500mg or less of famciclovir for the treatment of herpes labialis (cold sores). All other famciclovir preparations continue to be Rx. |
| Idoxuridine (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | 1996 | Australia | OTC | Switched in 1996 from S3 (pharmacist only) to S2 (pharmacy only) in preparations containing max 0.5% of idoxuridine for dermal use. In September 1999, S2 to GSL switch for preparations containing 0.5% or less for dermal use. |
| Lysozyme HCl | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | Australia | N.R. | Not registered or not marketed. |
| Mupirocin (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | Australia | Rx | — |
| Penciclovir (topical) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | 1998 | Australia | OTC | In 1998, switched from S4 (prescription) to S2 (pharmacy only) in preparations for dermal use containing 1% or less of Penciclovir. In September 1999, the S2 entry was amended to include preparations for external use for the treatment of herpes labialis. Effective 1 October 2017, S2 to GSL switch for penciclovir in preparations containing 1 per cent or less of penciclovir for the treatment of herpes labialis in packs containing 10 g or less. |
| Podofilox (Podophyllotoxin) | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | Australia | OTC | S2 (pharmacy only) in preparations for external therapeutic use containing max 2% of podophyllotoxin. S3 (pharmacist only) in preparations for external therapeutic use containing more than 2% but not more than 4% of podophyllotoxin. In December 2001, S2 to S3 reverse switch for preparations containing more than 0.5% but not more than 1% of podophyllotoxin for the treatment of warts other than anogenital warts. Also, S2 to S4 (prescription) reverse switch for preparations containing more than 1% of podophyllotoxin for the treatment of warts. No advertising to consumers is permitted. |
| Silver sulphadiazine 1% | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | Australia | Rx | — |
| Tetracycline | D Dermatologicals. Dermatologicals | D06. Antibiotics and chemotherapeutics for dermatological use | — | Australia | Rx | — |
| Alclometasone (topical) | D Dermatologicals. Dermatologicals | D07. Corticosteroids, dermatological preparations | 2000 | Australia | OTC | Effective September 2000, rescheduled from S4 (prescription) to S3 (pharmacist only) as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of alclomethasone (alclometasone) in packs containing 30g or less of the preparation. Cannot be advertised to consumers. |
| Clobetasone butyrate (topical) | D Dermatologicals. Dermatologicals | D07. Corticosteroids, dermatological preparations | 2002 | Australia | OTC | Effective September 2002, dermal preparations containing less than 0.05% clobetasone 17-butyrate in packs of less than 30g were switched to S3 (pharmacist only) status. Effective September 2003, limitation to single active ingredient formulations for dermal use of max 0.05% clobetasone in packs of maximum 30g. Effective September 2007, Appendix H entry deleted (S3 product can no longer be advertised to consumers). |
| Hydrocortisone (topical) | D Dermatologicals. Dermatologicals | D07. Corticosteroids, dermatological preparations | 1995 | Australia | OTC | In December 1995, rescheduled from S4 (prescription) to S3 (pharmacist only) as the only other therapeutically active substance in combination with max 0.5% of cinchocaine for topical rectal use in packs of max 30g. In September 1999, rescheduled from S4 to S3 in preparations containing max 1% for dermal use in packs of max 30g containing no other therapeutically active substance other than an antifungal (except when in S2). Rescheduled from S3 to S2 (pharmacy only) in preparations for dermal use containing 0.5% of hydrocortisone in packs of max 30g with no other therapeutically active substance except an antifungal. Effective January 2008, new S2 entry: Hydrocortisone and hydrocortisone acetate, but excluding other salts and derivatives, in preparations containing max 0.5% hydrocortisone: (a) for dermal use, in packs containing max 30g of such preparations containing no other therapeutically active constituent other than an antifungal substance; (b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents: - in undivided preparations in packs of max 35g, or - in packs containing max 12 suppositories. S3 entry: Hydrocortisone and hydrocortisone acetate, but excluding other salts and derivatives, in preparations containing max 1% of hydrocortisone: (a) for dermal use, in packs containing max 30g of such preparations, containing no other therapeutically active constituent other than an antifungal substance or (b) for rectal use when combined with a local anaesthetic but no other therapeutically active substance except unscheduled astringents: - in undivided preparations in packs of max 35g, or - in packs containing max 12 suppositories except when included in Schedule 2. S4: Hydrocortisone: (a) for human use except when included in Schedule 2 or 3, or (b) for the treatment of animals. S3: hydrocortisone single active ingredient products may be advertised to consumers. Also when in combination with unscheduled ingredients or with S3 antifungal ingredients. Effective 1 October 2015, Hydrocortisone for dermal use in preparations containing 1% or less of hydrocortisone for dermal use, in packs containing 2g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) in adults and adolescents (12 years of age and older). Effective 1 February 2016, S3 to S2 switch - Hydrocortisone for dermal use in preparations containing 1% or less of hydrocortisone, in packs containing 15g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent: i) for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and ii) not labelled for the treatment of children under 12 years of age. |
| Prednisolone | D Dermatologicals. Dermatologicals | D07. Corticosteroids, dermatological preparations | — | Australia | Rx | — |
| Triamcinolone | D Dermatologicals. Dermatologicals | D07. Corticosteroids, dermatological preparations | 1996 | Australia | OTC | Effective September 2004, S3 (pharmacist only) to S2 (pharmacy only) switch for aqueous nasal sprays (ATC code R01) delivering max 55 micrograms of triamcinolone per actuation when the maximum recommended daily dose is max 220 micrograms and when packed in a primary pack containing max 120 actuations, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over. (Effective 1 September 2006, the limit on number of actuations removed from the S2 entry.) Effective September 1996, S4 (prescription) to S3 (pharmacist only) switch for triamcinolone for the treatment of mouth ulcers (ATC code A01), in preparations containing max 0.1% of triamcinolone. Entry amended effective 1 May 2007 to triamcinolone for buccal use in preparations containing max 0.1% of triamcinolone in a pack of max 5g. Cannot be advertised to consumers. |
| Benzalkonium chloride | D Dermatologicals. Dermatologicals | D08. Antiseptics and disinfectants | — | Australia | OTC | General sale in preparations containing max 5% of benzalkonium chloride (some warning labels applied through the classification system). |
| Povidone iodine | D Dermatologicals. Dermatologicals | D08. Antiseptics and disinfectants | — | Australia | OTC | General sale. |
| Triclosan | D Dermatologicals. Dermatologicals | D08. Antiseptics and disinfectants | — | Australia | OTC | General sale. |
| Benzoyl peroxide | D Dermatologicals. Dermatologicals | D10. Anti-acne preparations | — | Australia | OTC | S2 (pharmacy only) in preparations for external therapeutic use containing max 5% of benzoyl peroxide. S3 (pharmacist only) in preparations for external therapeutic use containing more than 5% but not more than 10% of benzoyl peroxide. Rx: in preparations for external therapeutic use containing more than 10% of benzoyl peroxide. Effective 1 July 2000, rescheduled from S3 to S2 in preparations for human external therapeutic use containing max 10% of benzoyl peroxide except in preparations containing max 5% of benzoyl peroxide. Also rescheduled from S2 to GSL in preparations for human external use containing max 5% of benzoyl peroxide. |
| Clindamycin | D Dermatologicals. Dermatologicals | D10. Anti-acne preparations | — | Australia | Rx | — |
| Erythromycin (topical) | D Dermatologicals. Dermatologicals | D10. Anti-acne preparations | — | Australia | Rx | — |
| Tretinoin | D Dermatologicals. Dermatologicals | D10. Anti-acne preparations | — | Australia | Rx | — |
| Minoxidil (topical) | D Dermatologicals. Dermatologicals | D11. Other dermatological preparations | 1998 | Australia | OTC | In September 1998, switched from S4 (prescription) to S3 (pharmacist only) in preparations for dermal use containing max 2% of minoxidil. All other preparations S4. Effective March 2000, S3 in preparations for dermal use containing max 5% of minoxidil. All other preparations S4. Effective March 2002, rescheduled from S3 to S2 (pharmacy only) when in preparations for dermal use containing max 5% of minoxidil. |
| Butoconazole | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G01. Gynecological antiinfectives and antiseptics | 2007 | Australia | OTC | Effective May 2007: S4 (prescription) to S3 (pharmacist only) switch for preparations for vaginal use. All other preparations are S4. May be advertised to consumers. |
| Clotrimazole (vaginal) | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G01. Gynecological antiinfectives and antiseptics | 1994 | Australia | OTC | Rescheduled from S4 (prescription) to S3 (pharmacist only) in preparations for vaginal use in 1994. May be advertised to consumers. |
| Miconazole (vaginal) | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G01. Gynecological antiinfectives and antiseptics | 1994 | Australia | OTC | In 1994, switched from S4 (prescription) to S3 (pharmacist only) in topical preparations for vaginal use and when containing max 2% of miconazole for the treatment of oral candidiasis. Effective June 1999, concentration limitation removed i.e. miconazole for human use in topical preparations for treatment of oral candidiasis, or for vaginal use. May be advertised to consumers. |
| Propionate Ca+Na (vaginal) | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G01. Gynecological antiinfectives and antiseptics | — | Australia | N.R. | Not registered or not marketed. |
| Estriol (vaginal) | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G03. Sex hormones and modulators of the genital system | — | Australia | Rx | — |
| Levonorgestrel | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G03. Sex hormones and modulators of the genital system | 2004 | Australia | OTC | January 2004, S4 (prescription) to S3 (pharmacist only) switch for two 0.75mg tablet packs for emergency contraception. Levonorgestrel also in S4. Effective September 2006, S3 entry amended to read 'Levonorgestrel for emergency post-coital contraception'. Cannot be advertised to consumers. |
| Flavoxate hydrochloride | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G04. Urologicals | 1986 | Australia | OTC | Pharmacist-only (S3) medicine. No advertising to the general public permitted. |
| Phenazopyridine | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G04. Urologicals | — | Australia | Rx | — |
| Tamsulosin | G Genito urinary system and sex hormones. Genito urinary system and sex hormones | G04. Urologicals | — | Australia | Rx | — |