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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.
Cinchocaine (topical) N Nervous system. Nervous system N01. Anesthetics 1957 France OTC Topical forms: concentration up to 1%, maximum 500mg per pack. Other forms: concentration up to 0.1%, 5mg maximum per unit, maximum 50mg per pack. Also used in Rx combinations.
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.
Lidocaine (topical/oral topical) N Nervous system. Nervous system N01. Anesthetics 1958 France OTC Topical form: concentration up to 3%, maximum 3g per pack. Used as an anti-haemorrhoidal. ANSM regularization in 2023 Maximum exempt concentration: 2% - Maximum quantity of substance given to the public: 1g Mucosal administration: concentration up to 1%, maximum 200mg per pack. Indicated in sore throat of low intensity without fever, mouth ulcers and small mouth sores.
Brompheniramine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1968 France OTC Oral forms: maximum strength 0.05%, 12mg maximum per unit, maximum pack size 240mg. Topical forms: maximum strength 0.5%, maximum pack size 400mg. Suppositories: maximum dose 6mg, maximum pack size 60mg. Indicated in the relief of allergic symptoms (conjunctivitis, rhinitis, urticaria) in adults and children over 12 years. Reimbursable, therefore no public advertising authorised.
Miconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1983 France OTC In concentrations of 2%, 300mg per unit, maximum 2g per pack.
Econazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1983 France OTC Reimbursable, therefore no public advertising authorised.
Miconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1983 France OTC Concentration up to 2%. Maximum 1g per pack. Used in skin fungus. Reimbursable, therefore no public advertising allowed.
Isoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1983 France OTC Concentration up to 2%. Maximum 1g per pack.
Clotrimazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1983 France OTC Concentration 1%. Maximum 1g per pack.
Clotrimazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1983 France OTC In concentrations of 1%, 500mg per unit, maximum 1.2g per pack. Indicated in the treatment of yeast infection of vagina and vulva.
Ephedrine R Respiratory system. Respiratory system R01. Nasal preparations 1985 France OTC Nasal preparations are Rx. Non-prescription for oral and auricular use. Maximum 1g per pack (5%). Cannot be available directly over the counter.
Flubendazole P Antiparasitic products, insecticides and repellents. Antiparasitic products, insecticides and repellents P02. Anthelmintics 1987 France OTC Oral suspension: concentration up to 25%, maximum 600mg per pack. Tablets: maximum dose 100mg, up to 600mg per pack (i.e. 2%).
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.
Chlorproethazine (topical) N Nervous system. Nervous system N05. Psycholeptics 1988 France OTC Ointment: concentration up to 10%, maximum 3g per pack. No product currently marketed.
Idrocilamide M Musculo-skeletal system. Musculo-skeletal system M03. Muscle relaxants 1990 France OTC Cream, concentration: 5%. Maximum pack size: 3g. Indicated in the treatment of sprains and bruises in adults and children over 15 years.
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.
Ibuprofen (oral) M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1992 France OTC Solid oral forms: maximum dose 400mg (March 2007) and maximum 6g per pack. Liquid forms (switched in 2000): maximum concentration of 2g/100ml and maximum 4g per pack. Maximum treatment period for both presentations: 5 days. 200mg: for the short-term treatment of fever (maximum 3 days treatment) and pain (maximum 5 days treatment) in adults and children over 20kg. 400mg: for the short-term treatment of fever (maximum 3 days treatment) and pain (maximum 5 days treatment) not relieved by 200mg ibuprofen, in adults and children over 30kg.
Ibuprofen (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1996 France OTC Topical forms: maximum concentration 5% and maximum pack size 60g. Indicated in the treatment of sprains and bruises, tendinitis (this indication cannot be advertised to the public as a medical supervision is needed), in adults and children over 15 years.
Diclofenac (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1996 France OTC Maximum concentration 4% since May 2010. Maximum pack size 1g. For the short-term treatment of sprains and bruises in adults. All other forms are Rx.
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.
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.
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.
Ketoprofen M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1997 France OTC Non-prescription status for oral forms with a maximum dose of 25mg and a maximum pack size of 500mg.
Nicotine (gum) N Nervous system. Nervous system N07. Other nervous system drugs 1997 France OTC Maximum 4mg per unit. Up to 420mg per pack (2005).
Hydrocortisone (topical) D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1997 France OTC In concentrations of up to 0.5% and maximum pack size of 75mg. Indicated in insects bites, local sunburns and nettle stings in adults and children over 6 years.
Aciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 1997 France OTC Concentration up to 5%. Maximum100mg per pack. Indicated in the treatment of cold sores in adults and children over 6 years.
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.
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.
Ambroxol R Respiratory system. Respiratory system R05. Cough and cold preparations 1998 France OTC Oral form: 60mg per dose (0.6%). Maximum pack size 2g. Indicated in the treatment of acute bronchitis in adults.
Cromoglicic acid R Respiratory system. Respiratory system R01. Nasal preparations 1998 France OTC Eye drops: Maximum strength 2%. Maximum pack size 200mg. Nasal spray (2007): maximum strength 2%. Maximum pack size 300mg. Indicated in allergic rhinitis in adults and children. Also OTC under ATC code S01.
Niflumic acid (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1998 France OTC Skin application with a penetrating excipient: concentration up to 2.5%, maximum 1.5g per pack. Skin application with a non-penetrating excipient: concentration up to 3%, maximum 1.8g per pack. Indicated in the treatment of sprains and bruises, tendinitis (this indication cannot be advertised to the public as a medical supervision is needed), in adults and children over 15 years.
Cetirizine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1998 France OTC Oral form, 10mg per tablet, 70mg per pack. Indicated in allergic rhinitis and chronic urticaria (no public advertising authorised for the latter as needs medical supervision) in adults and children over 6 years.
Minoxidil (topical) D Dermatologicals. Dermatologicals D11. Other dermatological preparations 1998 France OTC Since January 2012: maximum concentration 5%, maximum 9g per pack. Indicated in the treatment of alopecia (excessive hair loss) in men aged between 18 and 65 years.
Ketoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1998 France OTC Concentration up to 1%. Maximum 1g per pack.
Nicotine (patch) N Nervous system. Nervous system N07. Other nervous system drugs 1999 France OTC Maximum strength 25mg/16 hours (2010) or 21mg/24 hours. Maximum pack size 28 x 25mg/16 hours (2010) or 28 x 21mg/24 hours.
Nicotine (sublingual) N Nervous system. Nervous system N07. Other nervous system drugs 1999 France OTC 4mg sublingual tablets are OTC and can be advertised to consumers. Up to 420mg per pack (2001).
Levonorgestrel G Genito urinary system and sex hormones. Genito urinary system and sex hormones G03. Sex hormones and modulators of the genital system 1999 France OTC The reclassification concerned the first non-prescription emergency contraceptive in the European Union to use levonorgestrel as a single ingredient (June 1999). Since December 2000: free and anonymous supply to women under 18. Available as one 1.5mg tablet (formerly also available as 2 x 0.75mg tablets).
Nicotine (oral inhaler) N Nervous system. Nervous system N07. Other nervous system drugs 1999 France OTC Oral spray. Maximum strength 10mg. Maximum pack size 420mg.
Penciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 2000 France OTC 1% cream. Maximum pack size 20mg.
Beclometasone (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 2002 France OTC Nasal spray: up to 100 micrograms per unit (50 micrograms in each nostril), maximum 5mg per pack. Indicated in allergic rhinitis in adults and children over 15 years.
Terbinafine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2002 France OTC Concentration up to 1%. Maximum 100mg per pack. For the treatment of athlete's foot in adults.
Azelastine R Respiratory system. Respiratory system R01. Nasal preparations 2005 France OTC Nasal spray. concentration up to 0.1%, up to 0.14mg per unit, maximum 10mg per pack. Indicated in allergic rhinitis in adults and children over 12 years.
Flurbiprofen (lozenges) R Respiratory system. Respiratory system R02. Throat preparations 2005 France OTC Limit per unit 8.75mg, limit per pack 140mg. Indicated in acute sore throat in adults and children over 12 years. All forms other than lozenges are Rx.
Loratadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 2006 France OTC Loratadine 10mg tablets switched in November 2006. Daily dose 10mg. Maximum pack size 70mg. Indicated in allergic rhinitis in adults and children over 12 years.
Naproxen M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 2007 France OTC Oral forms: 220mg maximum per unit, maximum 3.3g per pack. Indicated in fever and pain in adults and children over 15 years.
Benzoyl peroxide D Dermatologicals. Dermatologicals D10. Anti-acne preparations 2007 France OTC Concentration up to 5%. Maximum 5g per pack. Moderate acne.
Racecadotril A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents 2008 France OTC Occasional diarrhea in adults. 100mg maximum per unit, maximum 1g per pack.
Levocabastine R Respiratory system. Respiratory system R01. Nasal preparations 2009 France OTC Nasal preparations are Rx. Levocabastine in eye drops in a maximum concentration of 0.05% w/w was switched to non-prescription status on 15 December 2009. Maximum pack size 2.5mg.
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.
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