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Ingredient | ATC Level 1 | ATC Level 2 | Year Of Switch | Country | Status | Additional Information |
---|---|---|---|---|---|---|
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Argentina | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Australia | Rx | Effective 1 February 2018, codeine was switched to Rx. S2 (pharmacy only) when used in cold and flu products: Codeine in preparations for the treatment of coughs and colds when: (a) not combined with any other opiate substance; (b) compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance: (i) in divided preparations containing <10mg of codeine per dosage unit; or (ii) in undivided preparations containing <0.25% of codeine; (c) labelled with a recommended daily dose not exceeding 60mg of codeine; and (d) in packs containing not more than 6 days of supply at the maximum dose recommended on the label. . |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Austria | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Belgium | Rx | Associations of analgesics with codeine were back-switched to Rx on 1 March 2002. Antitussives with codeine were back-switched in May 2013. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Bulgaria | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | 2002 | Canada | OTC | 8mg. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Chile | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | China | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Colombia | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Croatia | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Czech Republic | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | 1984 | Denmark | OTC | In combination with acetylsalicylic acid. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Estonia | OTC | Not registered or not marketed under this ATC code. OTC under ATC code N02 in combination ('Paracetamol + Codeine' and 'Paracetamol + Codeine + Caffeine'). |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Finland | OTC | Mixture of codeine phosphate hemihydrate and guaifenesin, oral solution. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | France | Rx | Back-switched in July 2017. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Germany | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Greece | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Hungary | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Ireland | OTC | Supply through pharmacies only. Maximum strength 1.5%, maximum dose 20mg. Advertising to the public is prohibited. Combination with acetylsalicylic acid possible under these restrictions. As of 1 August 2010 codeine-containing OTC medicines in the pharmacy must be stored out of view (e.g. dispensary) and pharmacist consultation is typical before purchase is permitted. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Italy | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Japan | OTC | Only 13 years of age and over is allowed. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Lithuania | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Mexico | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | New Zealand | OTC | Pharmacist-only or pharmacy-only when combined with other active ingredients. It also has controlled drug status. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Norway | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Philippines | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Poland | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Portugal | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Romania | Rx | Tablets Therapeutic indications: - Pain of mild to moderate intensity, as an analgesic. Codeine is indicated in patients over 12 years of age for the treatment of moderate acute pain, which is not considered to be relieved by other analgesics, such as paracetamol or ibuprofen (alone). - Symptomatic treatment in case of non-productive irritating cough or diarrhoea. Doses: Codeine should be used in the minimum effective dose and for the shortest period of time. This one dose can be administered up to 4 times a day, at intervals of at least 6 hours. Maximum daily dose of codeine must not exceed 240 mg |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Russia | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Singapore | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Slovak Republic | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Slovenia | OTC | In combination with other analgesics. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | South Korea | — | No information. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Spain | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Sweden | Rx | — |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Switzerland | OTC | Maximum single dose 20mg codeine phosphate hemihydrate. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | The Netherlands | OTC | For the relief of tickling cough in adults and children over 12 years of age. Maximum strength 0.39mg/ml, maximum pack size 200ml. Codeine tablets and combinations with paracetamol have Rx status. UAD distribution status (Pharmacy and drugstore only). Public advertising not allowed. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | UK | Rx | Reclassified to a prescription-only medicine in 2024. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | USA | — | Status varies. Low dose codeine for cough in combination with other actives is a controlled substance but can be sold without a prescription in roughly half of the US states. Rx in remaining states. Codeine pain indication is Rx and 18 or older. |
Codeine | R Respiratory system. Respiratory system | R05. Cough and cold preparations | — | Venezuela | Rx | — |
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