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| Ingredient | ATC Level 1 | ATC Level 2 | Year Of Switch | Country | Status | Additional Information |
|---|---|---|---|---|---|---|
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2005 | Argentina | OTC | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | Australia | OTC | S4 (prescription) to S3 (pharmacist only) on 1 September 2010 in oral preparations containing 20mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply. Effective 1 February 2016, approval of Appendix H entry for Omeprazole, allowing direct-to-consumer advertising. Effective 1 June 2016, S3 to S2 switch for omeprazole in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days’ supply. Other entries in S3 and S4 |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Austria | OTC | Omeprazole 20mg for the treatment of heartburn. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2009 | Belgium | OTC | Omeprazole 10mg and 20mg for the treatment of duodenal ulcer, esophagitis and gastro duodenal ulcer. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Bulgaria | OTC | Omeprazole 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. Pack sizes 7 or 14 tablets. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2014 | Canada | OTC | OTC when indicated for a 14-day treatment of frequent heartburn at a daily dose of 20mg. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Chile | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | China | OTC | 10mg tablets or capsules. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Colombia | OTC | Maximum strength 10mg in capsules. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Croatia | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Czech Republic | OTC | Omeprazole 10mg and 20mg for the treatment of heartburn and hyperacidity in adults. Maximum daily dose 20mg. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Denmark | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Estonia | OTC | Omeprazole 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. Pack sizes 7 or 14 tablets. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | Finland | OTC | Omeprazole 20mg. For the short-term treatment of acid reflux. Maximum treatment time in self-care: two weeks. Only for adults. |
| 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. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2009 | Germany | OTC | Omeprazole 20mg oral formulations for the treatment of heartburn and gastric reflux. Maximum daily dose 20mg, maximum pack size 14 doses, maximum duration of treatment 14 days. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Greece | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Hungary | OTC | Omeprazole 20mg for the treatment of heartburn and hyperacidity. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2013 | Ireland | OTC | Omeprazole 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. Pack sizes 7 or 14 tablets. Supply through pharmacies only. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2011 | Italy | OTC | Omeprazole 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. Pack sizes 7 or 14 tablets. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Japan | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Lithuania | OTC | Omeprazole 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. Pack sizes 7 or 14 tablets. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Mexico | OTC | Indicated in the prevention and short-term relief of heartburn and acid reflux in adults over 18 years of age. Maximum strength 20mg, maximum daily dose 20mg, maximum pack size 28 capsules. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | New Zealand | OTC | In November 2010 omeprazole, in tablets containing 20mg or less of omeprazole, with a maximum daily dose of 20mg of omeprazole in a pack size of up to 14 dosage units, was reclassified from 'restricted medicine' to 'pharmacy-only medicine' for the short-term, symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine. Medsafe should update the New Zealand Regulatory Guide-lines to reflect this recommendation and ensure that the warnings statements for omeprazole read "consult a pharmacist or doctor". |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Norway | OTC | Omeprazole 20mg oral formulations for the treatment of heartburn and gastric reflux. Maximum daily dose 20mg, maximum pack size 14 doses, maximum duration of treatment 14 days. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Philippines | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2009 | Poland | OTC | Omeprazole 20mg for the treatment of heartburn. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Portugal | OTC | Omeprazole 10mg and 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. Pack sizes 7 or 14 tablets. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Romania | OTC | ~This medicine should not be used in children and adolescents under 18 years of age ~The recommended dose is 20 mg once a day for 14 days. ~Gastroresistant capsules |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Russia | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Singapore | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Slovak Republic | OTC | Omeprazole 20mg for the treatment of heartburn. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Slovenia | OTC | Omeprazole 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. Pack sizes 7 or 14 tablets. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | South Korea | Rx | — |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2003 | Spain | OTC | Omeprazole 10mg was switched to non-prescription status in 2003 for the short-term treatment of heartburn. Maximum daily dose 20mg. Maintenance treatment 10mg. Maximum treatment period 4 weeks. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1999 | Sweden | OTC | OTC status applies to treatment of symptoms of gastro-oesophageal reflux disease (e.g. heartburn, regurgitation) and for short-term treatment of up to 14 days. Dosage 10mg and 20mg. Maximum pack size 30 units. Maximum pack size for general sale supply: 14 x 10mg gastro-resistant tablets and 7 x 20mg tablets. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Switzerland | OTC | Omeprazole 20mg for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults, once daily for 14 days. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2010 | The Netherlands | OTC | Omeprazole 10mg and 20mg for the relief of heartburn and acid reflux. Maximum pack size 28 tablets. Omeprazole was immediately given UAD (pharmacy and druggist) distribution status in the Netherlands. In February 2016, omeprazole was allowed for AV distribution status (General sale) under the following conditions: for adults only and maximum 7 tablets of maximum 20mg. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2004 | UK | OTC | Pharmacy-only medicine for the relief of reflux-like symptoms such as heartburn in adults aged 18 years and over. Maximum treatment period 2 weeks. Maximum strength 20mg, maximum dose 20mg, maximum daily dose 20mg, maximum pack size 14 tablets. 10mg capsules reclassified to P in 2004. 20mg gastro-resistant capsules reclassified to P in 2013. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2003 | USA | OTC | Omeprazole 20mg/day acid reducer to treat frequent heartburn. 20mg Omeprazole and 1100mg Sodium bicarbonate to treat frequent heartburn switched to non-prescription status in December 2009. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | Venezuela | Rx | — |
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