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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 | 1957 | France | OTC | 3% or 0.05g maximum per dose and maximum 5g per pack. Prevention of tooth decay. Adults and children over 10 years. |
Hexetidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A01. Stomatological preparations | — | France | OTC | For the treatment of sore throat of low intensity without fever, mouth ulcers and small mouth sores. |
Aluminium hydroxide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | OTC | For the treatment of heartburn in adults. |
Calcium carbonate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | OTC | For the treatment of heartburn in adults. |
Carbenoxolone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | N.R. | Not registered or not marketed. |
Cetraxate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | N.R. | Not registered or not marketed. |
Cimetidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1997 | France | OTC | Oral form: 200mg maximum per unit. Maximum daily dose: 400mg. Maximum 2g per pack. For the treatment of heartburn in adults and children over 15 years. |
Famotidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1997 | France | OTC | Oral form: 10mg maximum per unit, maximum 120mg per pack. For the treatment of heartburn in adults and children over 15 years. |
Lansoprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | Rx | — |
Nizatidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | Rx | — |
Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | France | OTC | Omeprazole 20mg oral formulations for heartburn and acid reflux. Maximum pack size 280mg. Recommended daily dose: one 20mg tablet. Maximum duration of treatment 2 weeks. |
Pantoprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2009 | France | OTC | Pantoprazole 20mg was switched to non-prescription status in the entire European Union through a Decision of the European Commission under the centralised procedure dated 12 June 2009. Maximum 280mg per pack. Recommended daily dose: one 20mg tablet. Maximum duration of treatment: 2 weeks. |
Rabeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | Rx | — |
Ranitidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1997 | France | OTC | 75mg maximum per unit, maximum 900mg per pack. |
Sucralfate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | France | OTC | For the treatment of peptic ulcer (no public advertising allowed due to the indication). Formerly reimbursable. |
Dicyclomine (Dicycloverine) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | France | N.R. | Not registered or not marketed. |
Dimeticone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | France | OTC | Bloating, flatulence and heartburn in adults and children over 15 years. |
Domperidone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | France | Rx | — |
Hyoscine butylbromide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | France | Rx | — |
Mebeverine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | France | Rx | — |
Metoclopramide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | France | Rx | — |
Propantheline | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | France | N.R. | Not registered or not marketed. |
Dimenhydrinate (diphenhydramine and 8-chlorotheophylline) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A04. Antiemetics and antinauseants | — | France | OTC | For the treatment of travel sickness in adults and children over 2 years, and nausea and vomiting in adults and children over 6 years. Withdrawn from self-selection in 2015 due to abuse effects. |
Hyoscine (Scopolamine) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A04. Antiemetics and antinauseants | — | France | Rx | — |
Hymecromone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A05. Bile and liver therapy | 1990 | France | OTC | Oral, up to 0.4g maximum per unit, maximum 12g per pack. For the relief of digestive pains in adults. |
Bisacodyl | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | France | OTC | Occasional constipation in adults and children over 6 years. Public advertising for children below 18 years not allowed. |
Lactitol | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | France | OTC | Occasional constipation in adults and children over 6 years. Public advertising for children below 18 years not allowed. |
Lactulose | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | France | OTC | Occasional constipation in adults and children over 6 years. Public advertising for children below 18 years not allowed. |
Macrogol (Polyethylene glycol 3350) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | France | OTC | Indicated in temporary constipation in adults and children over 6 months. |
Picosulfate (sodium) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | France | OTC | Occasional constipation in adults. |
Loperamide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents | 1998 | France | OTC | 2mg/dose and 24mg per pack. Occasional diarrhea in adults. |
Nifuroxazide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents | 1998 | France | OTC | Antiseptic for intestinal use in acute diarrhoea presumed of bacterial origin, maximum oral dose 200mg, maximum pack size 2.4g. Public advertising is not authorised. |
Orlistat | A Alimentary tract and metabolism. Alimentary tract and metabolism | A08. Antiobesity preparations | 2009 | France | OTC | Orlistat 60 mg was switched to non-prescription status under the centralised procedure in the entire European Union through a European Commission Decision dated 12 January 2009. The switch was also implemented in Croatia, Norway and Switzerland. |
Vitamin A (Retinol) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A11. Vitamins | — | France | OTC | OTC indication: cutaneous irritation. In 1997, Vitamin A was back-switched to Rx in oral forms and over 50,000 UI/unit/24h and over 150,000 UI maximum per pack. |
Selenium | A Alimentary tract and metabolism. Alimentary tract and metabolism | A12. Mineral supplements | — | France | OTC | Mostly used in homeopathic preparations. Indicated in fatigue. |
Tranexamic acid | B Blood and blood forming organs. Blood and blood forming organs | B02. Antihemorrhagics | — | France | Rx | — |
Adenosine | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | — | France | OTC | Indicated in hemorrhoidal crisis and venous insufficiency. |
Nitro-glycerine | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | 1957 | France | OTC | All forms are OTC. 0.002% per intake, 0.0004g per unit and maximum 0.004g per pack. No product currently marketed. |
Ubidecarenone | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | — | France | N.R. | Not registered or not marketed. |
Lovastatin | C Cardiovascular system. Cardiovascular system | C10. Lipid modifying agents | — | France | N.R. | Not registered or not marketed. |
Simvastatin | C Cardiovascular system. Cardiovascular system | C10. Lipid modifying agents | — | France | Rx | — |
Amorolfine (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 2010 | France | OTC | Concentration up to 5%. Maximum pack size 125mg. Used in nail fungus in adults. |
Bifonazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | France | Rx | — |
Butenafine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | France | N.R. | Not registered or not marketed. |
Ciclopirox Olamine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1987 | France | OTC | Only in topical forms for use in skin and nail fungus and in mild to moderate facial seborrheic dermatitis. Maximum strength 1%. Maximum pack size 500mg. Reimbursable, therefore no public advertising allowed. |
Clotrimazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1983 | France | OTC | Concentration 1%. Maximum 1g per pack. |
Croconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | France | N.R. | Not registered or not marketed. |
Econazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1983 | France | OTC | Reimbursable, therefore no public advertising authorised. |
Fenticonazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | France | OTC | Cream, concentration up to 2%. |
Fluconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | France | Rx | — |
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