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Ingredient ATC Level 1 ATC Level 2 Year Of Switch Country Status Additional Information
Hyoscine butylbromide A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders 1966 Germany OTC —
Natamycin (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1978 Germany OTC External use.
Diphenylpyraline R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1979 Germany OTC No product currently marketed.
Isoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1983 Germany OTC External use.
Ambroxol R Respiratory system. Respiratory system R05. Cough and cold preparations 1984 Germany OTC OTC for all age groups.
Ciclopirox Olamine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1986 Germany OTC For topical use.
Fluoride (sodium) A Alimentary tract and metabolism. Alimentary tract and metabolism A01. Stomatological preparations 1986 Germany OTC Maximum daily dose of 2mg is OTC. Gel for topical use in dentistry is OTC. Packs up to 25g. For adults and children over 6 years. Maximum dose of 7mg of fluoride to be applied once a week.
Benproperine R Respiratory system. Respiratory system R05. Cough and cold preparations 1988 Germany OTC —
Bifonazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1988 Germany OTC —
Ibuprofen (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1989 Germany OTC External use: Maximum strength 5% and maximum quantity of product 60g. Patch (OTC as from 1 December 2017): strength 6%. Rectal use: Suppositories switched to OTC status in 2001 for the treatment of mild to moderate pain and fever.
Ibuprofen (oral) M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1989 Germany OTC In 1996 also authorised in liquid form as an analgesic. From July 1998, the allowed maximum dose was raised to 400mg (instead of 200mg) and the maximum daily dose to 1200mg (instead of 800mg). From July 2005, ibuprofen became available without a prescription for the treatment of migraine headaches with and without aura. In March 2013, ibuprofen 400mg combined with pseudoephedrine 60mg (maximum daily dose 1,200mg/180mg) was switched to treat acute rhino-sinusitis with symptoms of a cold like fever and pain. Ibuprofen is also OTC in rectal use: suppositories were switched in 2001 for the treatment of mild to moderate pain and fever. As from 1 July 2018, the 'Analgetika-Warnhinweis-Verordnung' obliges marketing authorisation holders to place a warning (advising patients not to use the product in case of pain or fever longer than specified in the leaflet without seeking medical advice) on the outer packaging of their OTC products containing one of the following active substances: Acetylsalicylic acid, Diclofenac, Ibuprofen, Naproxen, Paracetamol, Phenazone or Propyphenazone. From 1 October 2018, the combination of Ibuprofen 400mg (max daily dose 1,200mg) and Caffeine 100mg (max daily dose 300mg) is available OTC for the treatment of mild to moderate pain in adults.
Oxiconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1989 Germany OTC Except vaginal use which remains Rx.
Naftifine (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1990 Germany OTC —
Selenium sulphide D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1992 Germany OTC —
Aciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 1992 Germany OTC Ointment for the treatment of herpes labialis. Pack size 2g maximum, single dose up to 100mg. As from 1 December 2017, combination of aciclovir and hydrocortisone (1%) is OTC for the treatment of herpes labialis in adults and children over 12 years of age, maximum pack size 2g, maximum 100mg aciclovir per dosage form.
Tioconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1992 Germany OTC External use.
Ketoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1992 Germany OTC External use.
Selenium A Alimentary tract and metabolism. Alimentary tract and metabolism A12. Mineral supplements 1993 Germany OTC Maximum dose for OTC status is 70 micrograms.
Loperamide A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents 1993 Germany OTC Maximum daily dose for OTC use 12mg, restricted to treatment of acute diarrhoea. Maximum pack size 24mg. Without prescription only for adults and children over 12 years.
Acetylcysteine R Respiratory system. Respiratory system R05. Cough and cold preparations 1994 Germany OTC OTC for common cold in adults and children over 6 years of age. Rx for the treatment of chronic diseases in all age groups.
Nicotine (patch) N Nervous system. Nervous system N07. Other nervous system drugs 1994 Germany OTC —
Nicotine (gum) N Nervous system. Nervous system N07. Other nervous system drugs 1994 Germany OTC On 1 July 2004, all oral forms of nicotine and its salts gained non-prescription status for a single dose of 10mg and a maximum daily dose of 64mg.
Etofenamate (topical) M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1994 Germany OTC —
Piroxicam (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1994 Germany OTC —
Loratadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1994 Germany OTC —
Clotrimazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1994 Germany OTC Maximum pack size 600mg, 3 single doses, duration of treatment 3 days.
Felbinac (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1995 Germany OTC —
Cetirizine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1995 Germany OTC No limitation, e.g. in dosage, package size or indication.
Lactitol A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives 1995 Germany OTC —
Indomet(h)acin M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1996 Germany OTC 1% solution for external application.
Miconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1996 Germany OTC For the treatment of vaginal mycosis. Maximum pack size 1043mg, duration of treatment 3 days.
Hydrocortisone (topical) D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1996 Germany OTC Effective July 1996 (the first switch of its category in Germany). Hydrocortisone or hydrocortisone acetate up to 0.25% for all indications, for adults and children over 6 years of age, Pack size 50g. Hydrocortisone or hydrocortisone acetate from 0.25% up to 0.5% for the short-time treatment (max. 2 weeks) of phlogistic or allergic skin diseases and pruritus, for adults and children over 6 years of age, Pack size 30g. Hydrocortisone combined with aciclovir: see "Aciclovir".
Fenticonazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1996 Germany OTC —
Beclometasone (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 1997 Germany OTC For symptomatic relief of seasonal allergic rhinitis with adults in nasal applications following an initial diagnosis by a medical doctor and for daily dosage up to 400 μg provided the labeling restricts use to adults.
Azelastine R Respiratory system. Respiratory system R01. Nasal preparations 1997 Germany OTC For intranasal use in seasonal allergic rhinitis in adults and children over 6 years (switch in January 1997). Switch of eye drops approved at the end of 2002.
Levocabastine R Respiratory system. Respiratory system R01. Nasal preparations 1998 Germany OTC —
Croconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1998 Germany OTC For topical treatment against mycosis of the skin and nails.
Famotidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1999 Germany OTC Dosage 10mg. For the short-term treatment of heartburn and reflux in adults and children over 16 years, with a maximum duration of two weeks.
Ranitidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1999 Germany OTC Oral use, dosage up to 75mg. For heartburn and reflux, with a maximum duration of two weeks.
Diclofenac (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1999 Germany OTC Maximum concentration of 5%. Indicated in the symptomatic treatment of joint and muscular pain.
Nicotine (sublingual) N Nervous system. Nervous system N07. Other nervous system drugs 2000 Germany OTC —
Naproxen M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 2001 Germany OTC Treatment of mild to moderate pain and fever. In 2002, single dose increased to 250mg, maximum daily dose to 750mg, maximum pack size to 7500mg. As from 1 July 2018, the 'Analgetika-Warnhinweis-Verordnung' obliges marketing authorisation holders to place a warning (advising patients not to use the product in case of pain or fever longer than specified in the leaflet without seeking medical advice) on the outer packaging of their OTC products containing one of the following active substances: Acetylsalicylic acid, Diclofenac, Ibuprofen, Naproxen, Paracetamol, Phenazone or Propyphenazone.
Terbinafine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2001 Germany OTC OTC status limited to external application forms.
Nicotine (oral inhaler) N Nervous system. Nervous system N07. Other nervous system drugs 2002 Germany OTC Maximum strength 10mg, maximum daily dose 64mg.
Flurbiprofen (lozenges) R Respiratory system. Respiratory system R02. Throat preparations 2004 Germany OTC Lozenges for the short-term symptomatic treatment of painful inflammations of the throat. Maximum daily dose: 50mg.
Diclofenac M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 2004 Germany OTC Oral form switched to OTC status in January 2004. Maximum single dose is 25mg, maximum daily dose is 75mg. As from 1 July 2018, the 'Analgetika-Warnhinweis-Verordnung' obliges marketing authorisation holders to place a warning (advising patients not to use the product in case of pain or fever longer than specified in the leaflet without seeking medical advice) on the outer packaging of their OTC products containing one of the following active substances: Acetylsalicylic acid, Diclofenac, Ibuprofen, Naproxen, Paracetamol, Phenazone or Propyphenazone.
Penciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 2005 Germany OTC Treatment of herpes labialis, maximum pack size 2g, maximum strength 20mg.
Naratriptan N Nervous system. Nervous system N02. Analgesics 2006 Germany OTC Naratriptan tablets switched to non-prescription status on 1 April 2006 in a single dose of up to 2.5mg and a maximum pack size of 5mg. In analogy with Almotriptan, the non-prescription conditions for Naratriptan were modified in 2009 to include an age restriction (use restricted to adults between 18 and 65) as well as the need for a prior diagnosis of migraine by a medical doctor.
Almotriptan N Nervous system. Nervous system N02. Analgesics 2009 Germany OTC Almotriptan was switched to non-prescription status in 2009 in solid oral form for the acute treatment of migraine attacks with or without aura in adults between 18 and 65 after prior diagnosis of migraine by a medical doctor, in a single dose of 12.5mg and a maximum pack size of 25mg.
Orlistat A Alimentary tract and metabolism. Alimentary tract and metabolism A08. Antiobesity preparations 2009 Germany 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.
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