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Active ingredient	Administration route	ATC level 1	ATC level 2	Year of switch	Country	Status	Indication	Strength	Additional information
Acetylcysteine	Oral	R	R05		Austria	OTC	Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with a disruption in mucus formation and transport. Acetylcysteine 100mg - soluble tablets are used in adults and Children aged two and over and teenagers.	100mg, 200mg, 600mg	For oral use.
Acetylcysteine	Oral	R	R05		Belgium	OTC	Chronic bronchitis, cystic fibrosis, acute respiratory tract disorders	200mg, 600mg, 2%, 4%	Adults and children over 2 years of age.
Acetylcysteine	Oral	R	R05		Bulgaria	OTC	Secretolytic treatment of acute and chronic bronchopulmonary diseases accompanied by impaired secretion formation and transmission in adults and adolescents over 2 and 14 years of age.	100mg, 200mg, 600mg
Acetylcysteine	Oral	R	R05		Croatia	OTC	Secretolytic treatment of acute and chronic bronchopulmonary diseases accompanied by disorder production and expulsion of mucus in adults, adolescents and children older than 2 years. Treatment of acute and chronic diseases of the respiratory system with	100mg, 200mg, 600mg tablet, 200mg/5ggranules	Pharma forms: Effervescent tablets,granules Distribution in pharmacies Advertising togeneral public allowed Administration starts from children older than 2 years of age
Acetylcysteine	Oral	R	R05		Czech Republic	OTC	For therapy in acute and chronic respiratory diseases pathways associated with the formation of viscous mucus and difficult expectoration (acute and chronic bronchitis, bronchiectasis, asthmatic bronchitis, bronchial asthma, bronchiolitis, cystic fibrosis	20mg/ml, 100mg, 200mg, 600mg,	Mucolytic treatment of acute respiratory diseases. Maximum strength 600mg or 20mg/ml, maximum single dose 600mg or 200mg, maximum daily dose 600mg.
Acetylcysteine	Oral	R	R05		Denmark	OTC	Secretolytic treatment in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport in adults (600mg), in adults, adolescents and children from 6 years of age (200mg).	200mg, 600mg	effervescent tablets.
Acetylcysteine	Oral	R	R05		Estonia	OTC	Secretolytic therapy in acute and chronic bronchopulmonary diseases accompanied by impaired formation and transport of mucus To liquefy the mucus and ease expectoration in cold-induced bronchitis	100mg, 200mg, 600mg, 20mg/ml	Pharma form: Powder for solution, effervescent tablet Age: children from 2 years, adolescents and adults. Medicinal product with marketing authorization
Acetylcysteine	Oral	R	R05	1987	Finland	OTC	Respiratory diseases, especially during acute bronchitis.	200mg, 600mg	Limit per pack 6g (200mg per unit). OTC for adults and adolescents over 12 years of age.
Acetylcysteine	Oral	R	R05		France	OTC	Treatment of bronchial secretion disorders, particularly during acute bronchial conditions: acute bronchitis and acute episode of chronic bronchopneumopathy.600mg: This medication is indicated in adults for the treatment of bronchial conditions in which	200mg, 600mg, 2%	200mg: adults and children aged 2 and over. 600mg: Other presentations and concentrations of acetylcysteine are better suited for children and adolescents. Not indicated in children under 2 years of age. 2%: children over 2 years of age.
Acetylcysteine	Oral	R	R05	1994	Germany	OTC	To liquefy mucus and make it easier to cough up in cold-related bronchitis.	100mg, 200mg, 600mg, 20mg/ml	Adults and children over 6 years of age (common cold).
Acetylcysteine	Oral	R	R05	2008	Greece	OTC	Respiratory diseases	100mg, 200mg	OTC: 100mg/sachet & 200mg/sachet: Rx: 600mg/sachet.
Acetylcysteine	Oral	R	R05		Hungary	OTC	Expectorant therapy, in acute and chronic bronchopulmonary diseases such as bronchitis (acute and chronic), chronic obstructive pulmonary disease, bronchiectasis, pneumonia. Diseases associated with abnormal mucus formation and mucus transport occurring i	100mg, 200mg, 600mg, 20mg/ml
Acetylcysteine	Oral	R	R05		Italy	OTC	Treatment for respiratory diseases characterized by dense and viscous hypersecretion, such as cough, phlegm and colds.	100mg, 200mg, 300mg, 600mg, 300mg/3ml
Acetylcysteine	Oral	R	R05		Lithuania	OTC	Mucus liquefaction in acute or chronic bronchial and lung diseases, during which the production and removal of mucus is disturbed.	200mg, 20mg/ml , 100mg, 600mg
Acetylcysteine	Oral	R	R05		Netherlands	OTC	Respiratory diseases, where a reduction in the viscosity of the bronchial secretion is required to facilitate expectoration, as in asthma, bronchitis, emphysema, cystic fibrosis and bronchiectasis.	100mg, 200mg, 600mg
Acetylcysteine	Oral	R	R05		Norway	OTC	Adults and children ≥6 years: Short-term treatment of viscous mucus in the respiratory tract.	200mg, 600mg	Effervescent tablets x10 pieces and x25 are exempt from prescription obligation.
Acetylcysteine	Oral	R	R05		Poland	OTC	Primarily reduces the viscosity of bronchial secretions and facilitates expectoration. Thin respiratory secretions and facilitate expectoration in patients with bronchitis associated with colds.	100mg, 200mg, 600mg, 20mg/ml
Acetylcysteine	Oral	R	R05		Portugal	OTC	Mucolytic adjuvant in the treatment of respiratory problems associated with hypersecretion of thick, viscous mucus	4%, 600mg, 40mg/ml, 200mg, 20mg/ml	Effervescent tablets (maximum dose 600mg, maximum pack size 20 units). Oral solution (40 mg/ml).
Acetylcysteine	Oral	R	R05		Romania	OTC	200mg: Secretolytic treatment in acute and chronic bronchopulmonary diseases accompanied by formation disorders and mucus transport in adults, adolescents and children over 2 years of age. 600mg: Secretolytic treatment in acute and chronic bronchopulmonar	100mg, 200mg, 600mg, 20mg/ml,	Pharmaceutical forms - capsules, effervescent tablets, powder for oral solution, injectable solution/solution for inhalation,granules for oral solution, oral solutionTherapeutic indications: Secretolytic therapy of respiratory tract diseases: laryngitis, acute and chronic sinusitis, otitis media. Eases coughing. Treatment of acute and chronic diseases of the respiratory tract accompanied by mucus formation and transport disorders: acute bronchitis, asthmatic bronchitis, in exacerbations of chronic broncho-pneumopathy, bronchiectasis, cystic fibrosis, bronchial asthma. Oral Rx: 300mg/3ml, 20mg/ml,
Acetylcysteine	Oral	R	R05		Slovak Republic	OTC	Secretolytic treatment in acute and chronic bronchopulmonary diseases, for additional treatment of laryngitis, tracheitis, sinusitis, otitis media, cystic fibrosis, bronchial asthma, bronchiolitis, emphysema.	600mg, 200mg, 400mg, 20mg/ml	20mg/ml indicated for adults and children older than 2 years
Acetylcysteine	Oral	R	R05		Slovenia	OTC	Treatment of diseases of the respiratory tract where it is necessary to reduce viscosity bronchial secretions to facilitate expectoration, such as asthma, bronchitis, emphysema, cystic fibrosis and bronchiectasis	200mg, 600mg, 20mg/ml	200 mg and 20 mg/ml: Adults and children over 2 years of age. 600 mg: Adults.
Acetylcysteine	Oral	R	R05	1996	Spain	OTC	Reduction of the viscosity of mucous secretions, facilitating their expulsion, in cold and flu processes for adults.	600mg, 200mg, 20mg/ml, 40mg/ml	Since 2001: in children from 6-12 maximum dose 100mg, maximum daily dose 300mg. In children from 12-18: maximum dose 200mg, maximum daily dose 600mg. In adults: maximum unit and daily dose 600mg. Also OTC for adults and children over 12 years of age in combination = "paracetamol (500mg) + acetylcysteine (200mg)".
Acetylcysteine	Oral	R	R05		Switzerland	OTC	All respiratory tract conditions that result in increased production of dense, viscous mucus that is difficult to expectorate, such as acute and chronic bronchitis, bronchial asthma, sinusitis, laryngitis, tracheitis, influenza and as an adjunct treatment	100mg, 200mg, 600mg	Adults and children over 2 years of age.
Acetylcysteine	Oral	R	R05		Cyprus	OTC	For the liquefaction of mucous secretions of the respiratory tract in cases of acute and chronic bronchopulmonary diseases (bronchitis, emphysema, tracheobronchitis, chronic asthmatic bronchitis).	20mg/ml, 200mg/5ml, 600mg	20 mg/ml: Adults and children aged 2 and over. 200 mg/5 ml: Adults and children aged 6 and over. 600 mg: Adults and children aged 12 and over.
Acetylcysteine	Oral	R	R05		Latvia	OTC	Secretolytic therapy in acute and chronic bronchopulmonary diseases, which proceed with mucus secretion and output disorders.	100mg, 200mg, 600mg
Acetylcysteine	Oral	R	R05		Luxembourg	OTC	In chronic bronchitis (with maintenance of a minimum lung function of ± 50% of normal), long-term treatment with acetylcysteine is indicated to decrease the risk and severity of exacerbations. In the case of cystic fibrosis, oral treatment can complement	200mg, 600mg	Proposed as a symptomatic treatment to thin mucosal and mucopurulent secretions in upper and lower respiratory tract disorders Adults and children > 7 years of age: 600 mg daily, in 1 to 3 doses Children 2 to 7 years of age: 400 mg (120 to 600 mg) daily in 2 or 3 doses Cystic fibrosis Adults and children > 6 years: 600 mg per day Children 2 to 6 years of age: 120 to 600 mg per day Acute respiratory tract diseases Adults and children > 7 years: 400 to 600 mg daily in 1 to 3 doses Children 2 to 7 years of age: 400 mg (120 to 600 mg) daily in 2 or 3 doses
Acetylcysteine	Oral	R	R05		Malta	OTC	In adults for the treatment of airway secretion in which a reduction in the viscosity of the bronchial secretions is required to facilitate expectoration, esp ecially during periods of acute bronchitis .	600mg
Acetylcysteine	Oral	R	R05		Ireland	Rx
Acetylcysteine	Oral	R	R05		Sweden	Rx
Acetylcysteine	Oral	R	R05		UK	Rx
Acetylsalicylic acid	Oral	N	N02		Austria	OTC	Symptomatic treatment of mild to moderate pain such as: Headaches, toothaches and period pains. To relieve pain and fever from colds and flu-like infections.	500mg, 100mg, 320mg	Up to 1g per dose and 3g per day. Children under 12 years of age only with medical prescription.
Acetylsalicylic acid	Oral	N	N02		Belgium	OTC	Inflammatory and degenerative disorders of the joints and peri-articular structures, exclusively for analgesic purposes and for short periods. Symptomatic treatment of mild to moderate pain and/or febrile conditions. Gastro-resistant tablet: Acute treatme	80mg, 100mg, 160mg, 325mg, 400mg, 500mg, 1000mg	Adults and children over 10 years of age. Do not administer in children under 20 kg.gastro-resistant tablet (80-160mg): Adults and adolscents over 16 years of age.
Acetylsalicylic acid	Oral	N	N02		Bulgaria	OTC	Ischemic heart disease and all clinical situations where prevention of platelet aggregation is recommended: a history of unstable angina, except during the acute phase; secondary prevention of myocardial infarction; prevention ofgraft occlusion after coro	75mg, 150mg
Acetylsalicylic acid	Oral	N	N02		Croatia	OTC	Indicated for: .- secondary prevention of myocardial infarction in patients with a history of myocardial infarction .- secondary prevention of stroke in patients with a history of stroke .- prevention of thromboembolism after operative or interventional	75mg, 100mg, 300mg, 500mg
Acetylsalicylic acid	Oral	N	N02		Czech Republic	OTC	Pains of mild and moderate intensity of various origins, eg: headache, joint and muscle pain accompanying flu-like illness, toothache, neuralgia, pain of vertebrogenic origin, febrile conditions, especially in flu-like illnesses and acute inflammations up	400mg, 500mg	Strength 500mg, maximum single dose 1g, maximum daily dose 4g. For the relief of mild to moderate pain, e.g. headache, toothaches, backaches, painful menstrual periods, muscle and joint pain accompanying flu and colds, fever, in patients over 16 years.
Acetylsalicylic acid	Oral	N	N02		Denmark	OTC	Acute and chronic ischemic heart disease. Prophylaxis against retro-thrombosis.	75mg, 150mg	In Denmark it is an over-the-counter medicines with conditional subsidy. It has the following supplement clause: Secondary prophylaxis of IHS, ischemic cerebral apoplexy, TCI and PAD. Atrial fibrillation. Primary prophylaxis of cardiovascular disease such as thrombosis and ACS in persons over 50 years of age with one or more of the following disorders: Hypertension, hypercholesterolaemia, diabetes mellitus, obesity (BMI > 30) and family history of AMI before the age of 55 in at least one parent or sibling . Polycythemia vera. Essential thrombocytosis. Idiopathic myelofibrosis. Unclassified myeloproliferative condition. It is OTC in combiations with caffeine (500+50mg) and in combination with codein (500+9,6mg)
Acetylsalicylic acid	Oral	N	N02		Estonia	OTC	Pain. Pyrexia. Prophylaxis of coronary thrombosis: .- in case of suspected myocardial infarction and after; .- in case of angina pectoris; .- after a coronary heart revascularization procedure. Prevention of cardiovascular disease cases with diabetes mell	75mg, 100mg, 160mg, 324mg, 500mg	It is restricted to secondary prevention with chronic treatment. Age: For adults, adolescents and children from the age of 12
Acetylsalicylic acid	Oral	N	N02		Finland	OTC	Prevention of thrombotic and thromboembolic arterial blockages	50mg, 100mg, 500mg, 200mg/25mg	Switched before 1965.
Acetylsalicylic acid	Oral	N	N02		France	OTC	In cases of pain and/or fever such as headaches, flu-like conditions, dental pain, aches. Gastro resistant tablet: It is used to reduce the risk of blood clots and thus prevent the occurrence of heart attack, stroke, and cardiovascular problems in patient	75mg, 100mg, 300mg, 320mg, 324mg, 500mg, 1g	Tablets 320 and 325g: adults and children from 20 kg (approximately from 6 years old). Tablets 500mg: adults and children from 30 kg (approximately 9 to 15 years old). Adults and children weighing 20 kg or more (i.e. approximately 6 years). Tablets 1g: adults and children over 50 kg (from approximately 15 years old).gastro-resistant tablet (15, 100, 300, 500mg): should not be administered to children and adolescents under 16 years of age, except on medical advice and when the benefit outweighs the risk.
Acetylsalicylic acid	Oral	N	N02		Germany	OTC	Symptomatic treatment for mild to moderate pain and/or fever. 1g: Acute treatment of headaches, e.g. caused by migraine attacks with or without aura or tension headaches.	100mg, 300mg, 500mg, 1g	Adults and children over 12 years of age. 1g: Adults and children over 16 years of age.
Acetylsalicylic acid	Oral	N	N02		Greece	OTC	headache and migraine attacks, neuralgia, myalgia, arthralgia, dental pain, dysmenorrhea, fever	100mg, 500mg	As antipyretic-analgesic for short term use in a dose of 1g, maximum daily dose: 3g. Children under 3 years: Rx.
Acetylsalicylic acid	Oral	N	N02		Hungary	OTC	Mild to moderate pain such as headache, toothache, backache, sore throat caused by colds, joint pain and period pain; also in cases of fever, chills and inflammation. For the relief of pain and fever symptoms in the case of a cold or flu.	500mg, 75mg, 324mg, 100mg, 300mg	Film tablets, powder, tablets, chewing tablets, effervescent tablets, capsules.
Acetylsalicylic acid	Oral	N	N02		Ireland	OTC	For the relief of mild to moderate pain, such as is associated with headache, toothache, neuralgia and period pains. Symptomatic relief in upper respiratory tract infections (such as feverishness, cold and flu, sore throat). Reduction of inflammation,	500mg, 300mg, 75mg	Maximum dose 650mg, maximum daily dose 4g. Not for use in children under 12 years of age. Supply throughgeneral sales or pharmacies (depending on the product). Condition of sale: General sale in blister packs containing not more than 16 unit dosage forms. Retail sale through pharmacies only in blister packs containing not more than 24 unit dosage forms The indications should be appropriate for self-diagnosis and self-treatment. Promotion to thegeneral public only for indications appropriate for self-diagnosis and self-treatment. Aspirin-containing medicinal products should not be administered to subjects under 16 years of age unless specifically indicated by a healthcare professional. Maximum pack size 16
Acetylsalicylic acid	Oral	N	N02		Italy	OTC	Treatment of neuralgia and toothache, muscle or menstrual pain, treatment of fever and flu or cold symptoms. Secondary prevention of Myocardial infarction, transient ischemic attacks (TIA) and ischemic accidents cerebrovascular accidents (CVA).	100mg, 400mg, 500mg, 75mg, 160mg, 300mg
Acetylsalicylic acid	Oral	N	N02		Lithuania	OTC	To relieve mild pain and reduce fever	100mg, 500mg, 325mg
Acetylsalicylic acid	Oral	N	N02		Netherlands	OTC	Symptomatic treatment for fever and/or mild to moderate pain.	100mg, 324mg, 500mg	100mg: Children from 3-12 years of age. 324mg-500mg: Adults and adolescents from 12 years of age.
Acetylsalicylic acid	Oral	N	N02		Norway	OTC	Adults and children >12 years (≥40 kg): Short-term treatment of mild to moderate pain, e.g. headache, menstrual cramps, toothache and muscle and joint pain. Adults >18 years: Short-term treatment of fever in colds and flu. Mild to moderate headache in adu	500mg	Pack sizes up to 20 tablets and 1 bottle (300mg) is exempt from prescription.
Acetylsalicylic acid	Oral	N	N02		Poland	OTC	Secondary prevention of myocardial infarction. .- Prevention of cardiovascular disease in patients with stable angina. .- History of unstable angina, except in the acute phase. .- Prevention of vasculargraft occlusion after coronary artery bypass surgery	75mg, 100mg, 150mg, 300mg, 30mg, 160mg, 330mg, 324mg	Pack up to 100 tablets (for 75mg and 100mg), Pack up to 60 tablets (150mg), x10 (300mg)(330mg), x40(324mg)
Acetylsalicylic acid	Oral	N	N02		Portugal	OTC	Symptomatic treatment of fever and/or mild to moderate pain.	500mg	100mg is Rx for some specific therapeutic indications.
Acetylsalicylic acid	Oral	N	N02		Romania	OTC	(1) symptomatic treatment for fever and/or mild to moderate pain(2) to reduce the risk myocardial infarction / recurrent transient ischaemic attacks or stroke /graft occlusion following aortocoronary by-pass surgery / myocardial ischaemic events	50mg, 75mg, 100mg, 324mg, 500mg, 1000mg	Age group(s) for which the medicine/ingredient is available without prescription: age 12 and older recommended dosage for non-prescription status(1) 500mg / 1000mg when required or after 4/8 h(2) 100-300mg per day pharmaceutical form: tablets, effervescent tablets, gastroresistant tablets, film-coated tablets maximum daily dose: 4000mg
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Active ingredient	Administration route	ATC level 1	ATC level 2	Year of switch	Country	Status	Indication	Strength	Additional information
Acetylcysteine	Oral	R	R05		Austria	OTC	Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with a disruption in mucus formation and transport. Acetylcysteine 100mg - soluble tablets are used in adults and Children aged two and over and teenagers.	100mg, 200mg, 600mg	For oral use.
Acetylcysteine	Oral	R	R05		Belgium	OTC	Chronic bronchitis, cystic fibrosis, acute respiratory tract disorders	200mg, 600mg, 2%, 4%	Adults and children over 2 years of age.
Acetylcysteine	Oral	R	R05		Bulgaria	OTC	Secretolytic treatment of acute and chronic bronchopulmonary diseases accompanied by impaired secretion formation and transmission in adults and adolescents over 2 and 14 years of age.	100mg, 200mg, 600mg
Acetylcysteine	Oral	R	R05		Croatia	OTC	Secretolytic treatment of acute and chronic bronchopulmonary diseases accompanied by disorder production and expulsion of mucus in adults, adolescents and children older than 2 years. Treatment of acute and chronic diseases of the respiratory system with	100mg, 200mg, 600mg tablet, 200mg/5ggranules	Pharma forms: Effervescent tablets,granules Distribution in pharmacies Advertising togeneral public allowed Administration starts from children older than 2 years of age
Acetylcysteine	Oral	R	R05		Czech Republic	OTC	For therapy in acute and chronic respiratory diseases pathways associated with the formation of viscous mucus and difficult expectoration (acute and chronic bronchitis, bronchiectasis, asthmatic bronchitis, bronchial asthma, bronchiolitis, cystic fibrosis	20mg/ml, 100mg, 200mg, 600mg,	Mucolytic treatment of acute respiratory diseases. Maximum strength 600mg or 20mg/ml, maximum single dose 600mg or 200mg, maximum daily dose 600mg.
Acetylcysteine	Oral	R	R05		Denmark	OTC	Secretolytic treatment in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport in adults (600mg), in adults, adolescents and children from 6 years of age (200mg).	200mg, 600mg	effervescent tablets.
Acetylcysteine	Oral	R	R05		Estonia	OTC	Secretolytic therapy in acute and chronic bronchopulmonary diseases accompanied by impaired formation and transport of mucus To liquefy the mucus and ease expectoration in cold-induced bronchitis	100mg, 200mg, 600mg, 20mg/ml	Pharma form: Powder for solution, effervescent tablet Age: children from 2 years, adolescents and adults. Medicinal product with marketing authorization
Acetylcysteine	Oral	R	R05	1987	Finland	OTC	Respiratory diseases, especially during acute bronchitis.	200mg, 600mg	Limit per pack 6g (200mg per unit). OTC for adults and adolescents over 12 years of age.
Acetylcysteine	Oral	R	R05		France	OTC	Treatment of bronchial secretion disorders, particularly during acute bronchial conditions: acute bronchitis and acute episode of chronic bronchopneumopathy.600mg: This medication is indicated in adults for the treatment of bronchial conditions in which	200mg, 600mg, 2%	200mg: adults and children aged 2 and over. 600mg: Other presentations and concentrations of acetylcysteine are better suited for children and adolescents. Not indicated in children under 2 years of age. 2%: children over 2 years of age.
Acetylcysteine	Oral	R	R05	1994	Germany	OTC	To liquefy mucus and make it easier to cough up in cold-related bronchitis.	100mg, 200mg, 600mg, 20mg/ml	Adults and children over 6 years of age (common cold).
Acetylcysteine	Oral	R	R05	2008	Greece	OTC	Respiratory diseases	100mg, 200mg	OTC: 100mg/sachet & 200mg/sachet: Rx: 600mg/sachet.
Acetylcysteine	Oral	R	R05		Hungary	OTC	Expectorant therapy, in acute and chronic bronchopulmonary diseases such as bronchitis (acute and chronic), chronic obstructive pulmonary disease, bronchiectasis, pneumonia. Diseases associated with abnormal mucus formation and mucus transport occurring i	100mg, 200mg, 600mg, 20mg/ml
Acetylcysteine	Oral	R	R05		Italy	OTC	Treatment for respiratory diseases characterized by dense and viscous hypersecretion, such as cough, phlegm and colds.	100mg, 200mg, 300mg, 600mg, 300mg/3ml
Acetylcysteine	Oral	R	R05		Lithuania	OTC	Mucus liquefaction in acute or chronic bronchial and lung diseases, during which the production and removal of mucus is disturbed.	200mg, 20mg/ml , 100mg, 600mg
Acetylcysteine	Oral	R	R05		Netherlands	OTC	Respiratory diseases, where a reduction in the viscosity of the bronchial secretion is required to facilitate expectoration, as in asthma, bronchitis, emphysema, cystic fibrosis and bronchiectasis.	100mg, 200mg, 600mg
Acetylcysteine	Oral	R	R05		Norway	OTC	Adults and children ≥6 years: Short-term treatment of viscous mucus in the respiratory tract.	200mg, 600mg	Effervescent tablets x10 pieces and x25 are exempt from prescription obligation.
Acetylcysteine	Oral	R	R05		Poland	OTC	Primarily reduces the viscosity of bronchial secretions and facilitates expectoration. Thin respiratory secretions and facilitate expectoration in patients with bronchitis associated with colds.	100mg, 200mg, 600mg, 20mg/ml
Acetylcysteine	Oral	R	R05		Portugal	OTC	Mucolytic adjuvant in the treatment of respiratory problems associated with hypersecretion of thick, viscous mucus	4%, 600mg, 40mg/ml, 200mg, 20mg/ml	Effervescent tablets (maximum dose 600mg, maximum pack size 20 units). Oral solution (40 mg/ml).
Acetylcysteine	Oral	R	R05		Romania	OTC	200mg: Secretolytic treatment in acute and chronic bronchopulmonary diseases accompanied by formation disorders and mucus transport in adults, adolescents and children over 2 years of age. 600mg: Secretolytic treatment in acute and chronic bronchopulmonar	100mg, 200mg, 600mg, 20mg/ml,	Pharmaceutical forms - capsules, effervescent tablets, powder for oral solution, injectable solution/solution for inhalation,granules for oral solution, oral solutionTherapeutic indications: Secretolytic therapy of respiratory tract diseases: laryngitis, acute and chronic sinusitis, otitis media. Eases coughing. Treatment of acute and chronic diseases of the respiratory tract accompanied by mucus formation and transport disorders: acute bronchitis, asthmatic bronchitis, in exacerbations of chronic broncho-pneumopathy, bronchiectasis, cystic fibrosis, bronchial asthma. Oral Rx: 300mg/3ml, 20mg/ml,
Acetylcysteine	Oral	R	R05		Slovak Republic	OTC	Secretolytic treatment in acute and chronic bronchopulmonary diseases, for additional treatment of laryngitis, tracheitis, sinusitis, otitis media, cystic fibrosis, bronchial asthma, bronchiolitis, emphysema.	600mg, 200mg, 400mg, 20mg/ml	20mg/ml indicated for adults and children older than 2 years
Acetylcysteine	Oral	R	R05		Slovenia	OTC	Treatment of diseases of the respiratory tract where it is necessary to reduce viscosity bronchial secretions to facilitate expectoration, such as asthma, bronchitis, emphysema, cystic fibrosis and bronchiectasis	200mg, 600mg, 20mg/ml	200 mg and 20 mg/ml: Adults and children over 2 years of age. 600 mg: Adults.
Acetylcysteine	Oral	R	R05	1996	Spain	OTC	Reduction of the viscosity of mucous secretions, facilitating their expulsion, in cold and flu processes for adults.	600mg, 200mg, 20mg/ml, 40mg/ml	Since 2001: in children from 6-12 maximum dose 100mg, maximum daily dose 300mg. In children from 12-18: maximum dose 200mg, maximum daily dose 600mg. In adults: maximum unit and daily dose 600mg. Also OTC for adults and children over 12 years of age in combination = "paracetamol (500mg) + acetylcysteine (200mg)".
Acetylcysteine	Oral	R	R05		Switzerland	OTC	All respiratory tract conditions that result in increased production of dense, viscous mucus that is difficult to expectorate, such as acute and chronic bronchitis, bronchial asthma, sinusitis, laryngitis, tracheitis, influenza and as an adjunct treatment	100mg, 200mg, 600mg	Adults and children over 2 years of age.
Acetylcysteine	Oral	R	R05		Cyprus	OTC	For the liquefaction of mucous secretions of the respiratory tract in cases of acute and chronic bronchopulmonary diseases (bronchitis, emphysema, tracheobronchitis, chronic asthmatic bronchitis).	20mg/ml, 200mg/5ml, 600mg	20 mg/ml: Adults and children aged 2 and over. 200 mg/5 ml: Adults and children aged 6 and over. 600 mg: Adults and children aged 12 and over.
Acetylcysteine	Oral	R	R05		Latvia	OTC	Secretolytic therapy in acute and chronic bronchopulmonary diseases, which proceed with mucus secretion and output disorders.	100mg, 200mg, 600mg
Acetylcysteine	Oral	R	R05		Luxembourg	OTC	In chronic bronchitis (with maintenance of a minimum lung function of ± 50% of normal), long-term treatment with acetylcysteine is indicated to decrease the risk and severity of exacerbations. In the case of cystic fibrosis, oral treatment can complement	200mg, 600mg	Proposed as a symptomatic treatment to thin mucosal and mucopurulent secretions in upper and lower respiratory tract disorders Adults and children > 7 years of age: 600 mg daily, in 1 to 3 doses Children 2 to 7 years of age: 400 mg (120 to 600 mg) daily in 2 or 3 doses Cystic fibrosis Adults and children > 6 years: 600 mg per day Children 2 to 6 years of age: 120 to 600 mg per day Acute respiratory tract diseases Adults and children > 7 years: 400 to 600 mg daily in 1 to 3 doses Children 2 to 7 years of age: 400 mg (120 to 600 mg) daily in 2 or 3 doses
Acetylcysteine	Oral	R	R05		Malta	OTC	In adults for the treatment of airway secretion in which a reduction in the viscosity of the bronchial secretions is required to facilitate expectoration, esp ecially during periods of acute bronchitis .	600mg
Acetylcysteine	Oral	R	R05		Ireland	Rx
Acetylcysteine	Oral	R	R05		Sweden	Rx
Acetylcysteine	Oral	R	R05		UK	Rx
Acetylsalicylic acid	Oral	N	N02		Austria	OTC	Symptomatic treatment of mild to moderate pain such as: Headaches, toothaches and period pains. To relieve pain and fever from colds and flu-like infections.	500mg, 100mg, 320mg	Up to 1g per dose and 3g per day. Children under 12 years of age only with medical prescription.
Acetylsalicylic acid	Oral	N	N02		Belgium	OTC	Inflammatory and degenerative disorders of the joints and peri-articular structures, exclusively for analgesic purposes and for short periods. Symptomatic treatment of mild to moderate pain and/or febrile conditions. Gastro-resistant tablet: Acute treatme	80mg, 100mg, 160mg, 325mg, 400mg, 500mg, 1000mg	Adults and children over 10 years of age. Do not administer in children under 20 kg.gastro-resistant tablet (80-160mg): Adults and adolscents over 16 years of age.
Acetylsalicylic acid	Oral	N	N02		Bulgaria	OTC	Ischemic heart disease and all clinical situations where prevention of platelet aggregation is recommended: a history of unstable angina, except during the acute phase; secondary prevention of myocardial infarction; prevention ofgraft occlusion after coro	75mg, 150mg
Acetylsalicylic acid	Oral	N	N02		Croatia	OTC	Indicated for: .- secondary prevention of myocardial infarction in patients with a history of myocardial infarction .- secondary prevention of stroke in patients with a history of stroke .- prevention of thromboembolism after operative or interventional	75mg, 100mg, 300mg, 500mg
Acetylsalicylic acid	Oral	N	N02		Czech Republic	OTC	Pains of mild and moderate intensity of various origins, eg: headache, joint and muscle pain accompanying flu-like illness, toothache, neuralgia, pain of vertebrogenic origin, febrile conditions, especially in flu-like illnesses and acute inflammations up	400mg, 500mg	Strength 500mg, maximum single dose 1g, maximum daily dose 4g. For the relief of mild to moderate pain, e.g. headache, toothaches, backaches, painful menstrual periods, muscle and joint pain accompanying flu and colds, fever, in patients over 16 years.
Acetylsalicylic acid	Oral	N	N02		Denmark	OTC	Acute and chronic ischemic heart disease. Prophylaxis against retro-thrombosis.	75mg, 150mg	In Denmark it is an over-the-counter medicines with conditional subsidy. It has the following supplement clause: Secondary prophylaxis of IHS, ischemic cerebral apoplexy, TCI and PAD. Atrial fibrillation. Primary prophylaxis of cardiovascular disease such as thrombosis and ACS in persons over 50 years of age with one or more of the following disorders: Hypertension, hypercholesterolaemia, diabetes mellitus, obesity (BMI > 30) and family history of AMI before the age of 55 in at least one parent or sibling . Polycythemia vera. Essential thrombocytosis. Idiopathic myelofibrosis. Unclassified myeloproliferative condition. It is OTC in combiations with caffeine (500+50mg) and in combination with codein (500+9,6mg)
Acetylsalicylic acid	Oral	N	N02		Estonia	OTC	Pain. Pyrexia. Prophylaxis of coronary thrombosis: .- in case of suspected myocardial infarction and after; .- in case of angina pectoris; .- after a coronary heart revascularization procedure. Prevention of cardiovascular disease cases with diabetes mell	75mg, 100mg, 160mg, 324mg, 500mg	It is restricted to secondary prevention with chronic treatment. Age: For adults, adolescents and children from the age of 12
Acetylsalicylic acid	Oral	N	N02		Finland	OTC	Prevention of thrombotic and thromboembolic arterial blockages	50mg, 100mg, 500mg, 200mg/25mg	Switched before 1965.
Acetylsalicylic acid	Oral	N	N02		France	OTC	In cases of pain and/or fever such as headaches, flu-like conditions, dental pain, aches. Gastro resistant tablet: It is used to reduce the risk of blood clots and thus prevent the occurrence of heart attack, stroke, and cardiovascular problems in patient	75mg, 100mg, 300mg, 320mg, 324mg, 500mg, 1g	Tablets 320 and 325g: adults and children from 20 kg (approximately from 6 years old). Tablets 500mg: adults and children from 30 kg (approximately 9 to 15 years old). Adults and children weighing 20 kg or more (i.e. approximately 6 years). Tablets 1g: adults and children over 50 kg (from approximately 15 years old).gastro-resistant tablet (15, 100, 300, 500mg): should not be administered to children and adolescents under 16 years of age, except on medical advice and when the benefit outweighs the risk.
Acetylsalicylic acid	Oral	N	N02		Germany	OTC	Symptomatic treatment for mild to moderate pain and/or fever. 1g: Acute treatment of headaches, e.g. caused by migraine attacks with or without aura or tension headaches.	100mg, 300mg, 500mg, 1g	Adults and children over 12 years of age. 1g: Adults and children over 16 years of age.
Acetylsalicylic acid	Oral	N	N02		Greece	OTC	headache and migraine attacks, neuralgia, myalgia, arthralgia, dental pain, dysmenorrhea, fever	100mg, 500mg	As antipyretic-analgesic for short term use in a dose of 1g, maximum daily dose: 3g. Children under 3 years: Rx.
Acetylsalicylic acid	Oral	N	N02		Hungary	OTC	Mild to moderate pain such as headache, toothache, backache, sore throat caused by colds, joint pain and period pain; also in cases of fever, chills and inflammation. For the relief of pain and fever symptoms in the case of a cold or flu.	500mg, 75mg, 324mg, 100mg, 300mg	Film tablets, powder, tablets, chewing tablets, effervescent tablets, capsules.
Acetylsalicylic acid	Oral	N	N02		Ireland	OTC	For the relief of mild to moderate pain, such as is associated with headache, toothache, neuralgia and period pains. Symptomatic relief in upper respiratory tract infections (such as feverishness, cold and flu, sore throat). Reduction of inflammation,	500mg, 300mg, 75mg	Maximum dose 650mg, maximum daily dose 4g. Not for use in children under 12 years of age. Supply throughgeneral sales or pharmacies (depending on the product). Condition of sale: General sale in blister packs containing not more than 16 unit dosage forms. Retail sale through pharmacies only in blister packs containing not more than 24 unit dosage forms The indications should be appropriate for self-diagnosis and self-treatment. Promotion to thegeneral public only for indications appropriate for self-diagnosis and self-treatment. Aspirin-containing medicinal products should not be administered to subjects under 16 years of age unless specifically indicated by a healthcare professional. Maximum pack size 16
Acetylsalicylic acid	Oral	N	N02		Italy	OTC	Treatment of neuralgia and toothache, muscle or menstrual pain, treatment of fever and flu or cold symptoms. Secondary prevention of Myocardial infarction, transient ischemic attacks (TIA) and ischemic accidents cerebrovascular accidents (CVA).	100mg, 400mg, 500mg, 75mg, 160mg, 300mg
Acetylsalicylic acid	Oral	N	N02		Lithuania	OTC	To relieve mild pain and reduce fever	100mg, 500mg, 325mg
Acetylsalicylic acid	Oral	N	N02		Netherlands	OTC	Symptomatic treatment for fever and/or mild to moderate pain.	100mg, 324mg, 500mg	100mg: Children from 3-12 years of age. 324mg-500mg: Adults and adolescents from 12 years of age.
Acetylsalicylic acid	Oral	N	N02		Norway	OTC	Adults and children >12 years (≥40 kg): Short-term treatment of mild to moderate pain, e.g. headache, menstrual cramps, toothache and muscle and joint pain. Adults >18 years: Short-term treatment of fever in colds and flu. Mild to moderate headache in adu	500mg	Pack sizes up to 20 tablets and 1 bottle (300mg) is exempt from prescription.
Acetylsalicylic acid	Oral	N	N02		Poland	OTC	Secondary prevention of myocardial infarction. .- Prevention of cardiovascular disease in patients with stable angina. .- History of unstable angina, except in the acute phase. .- Prevention of vasculargraft occlusion after coronary artery bypass surgery	75mg, 100mg, 150mg, 300mg, 30mg, 160mg, 330mg, 324mg	Pack up to 100 tablets (for 75mg and 100mg), Pack up to 60 tablets (150mg), x10 (300mg)(330mg), x40(324mg)
Acetylsalicylic acid	Oral	N	N02		Portugal	OTC	Symptomatic treatment of fever and/or mild to moderate pain.	500mg	100mg is Rx for some specific therapeutic indications.
Acetylsalicylic acid	Oral	N	N02		Romania	OTC	(1) symptomatic treatment for fever and/or mild to moderate pain(2) to reduce the risk myocardial infarction / recurrent transient ischaemic attacks or stroke /graft occlusion following aortocoronary by-pass surgery / myocardial ischaemic events	50mg, 75mg, 100mg, 324mg, 500mg, 1000mg	Age group(s) for which the medicine/ingredient is available without prescription: age 12 and older recommended dosage for non-prescription status(1) 500mg / 1000mg when required or after 4/8 h(2) 100-300mg per day pharmaceutical form: tablets, effervescent tablets, gastroresistant tablets, film-coated tablets maximum daily dose: 4000mg
		ATC level 1	ATC level 2	Year of switch	Country	Status

Instructions

Instructions for Using the AESGP Ingredients Directory

Self-care is vital for public health and the sustainability of healthcare systems. A clear distinction between prescription and non-prescription medicines (legal status) is essential for promoting responsible self-care. In the European Union, medicinal products are not subject to mandatory medical prescriptions unless they meet specific legal criteria (Article 72 of Directive 2001/83/EC, as amended).

The legal status of a medicine is typically a national decision, influenced by factors such as reclassification procedures, medical history, and authorities’ stance on self-care. This leads to significant variations in the legal status of medicines across countries, even for those with well-established active ingredients. Consequently, patients’ access to self-care options varies depending on their country of residence.

Further information about the legal and regulatory framework for non-prescription medicines across Europe, including national reclassification procedures, is available in our Med Data Bank.

The AESGP Ingredients Directory

The AESGP Ingredients Directory presents a non-exhaustive list of active substances that are available as non-prescription medicines and compares their classification status in 30 European countries. A major update was completed in May 2024 and it is now reviewed yearly.

Please note that only a limited number of combinations is available in the database. Should you wish to have additional ingredients or combination included please indicate as such in the “Submit a change form”.

How to Use the Directory

Status: “OTC” indicates that at least one dosage or form of the ingredient has non-prescription status in the specified country. This status is independent of the reimbursement or advertising status of products containing the ingredient.
For ingredients available as OTC, details are provided regarding indication, dosage, posology, and any limitations to the non-prescription status.
Disclaimer: The classification of ingredients is for informational purposes only. AESGP is not liable for the content or its use by third parties. Official classification is determined by national competent authorities.

Search Instructions

Basic Search: Start typing an ingredient name and select it from the list. Once satisfied with your terms, click the search button.
Advanced Search: Allows searching by parameters such as country, ATC level, year of switch, or legal status.

Tips&tricks

Sort: You may sort alphabetically each column by simply clicking on it.
Search adjustments: Any changes made after the initial search take place immediately, you do not need to click ‘search’ every time something is changes
Print: The results of a search can be easily exported via the ‘Print’ button for future reference

Submitting Changes

Year of switch
Pharmaceutical form
Indication(s) for non-prescription use
Recommended dosage for non-prescription status
Any limitations to OTC status (e.g., sub-classification, advertising restrictions)

Source of information to confirm validity.