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| Ingredient | ATC Level 1 | ATC Level 2 | Year Of Switch | Country | Status | Additional Information |
|---|---|---|---|---|---|---|
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Argentina | OTC | Oral 220mg. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1990 | Australia | OTC | Rescheduled from S3 (pharmacist only) to S2 (pharmacy only) in 1990 as the only therapeutically active substance in packs of max 12 dosage units for the treatment of spasmodic dysmenorrhoea. Effective June 1999, S4 (prescription) to S2 switch to allow for larger pack sizes and combinations permitted as S2 for the treatment of primary dysmenorrhoea i.e. naproxen in divided preparations containing max 250mg of naproxen per dosage unit in packs of max 20 dosage units for the treatment of dysmenorrhoea. Also in June 1999, rescheduled from S4 to S3 in divided preparations containing max 250mg of naproxen per dosage unit in packs of max 30 dosage units except when included in S2 for dysmenorrhoea (Otherwise Rx e.g. dermal or rectal application). Effective 1 July 2000, S3 to S2 switch in divided preparations containing max 250mg of naproxen per dosage unit in packs of max 30 dosage units. Effective 1 October 2014, new S3 entry for naproxen in a modified release dosage form of 600mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 2006 | Austria | OTC | For topical use against pain and swelling after blunt injuries, cramped muscle and lumbago. For internal use as analgesic up to 200mg per dose and 600mg per day. For children under 12 years on medical prescription only. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Belgium | OTC | Naproxen 220mg is OTC for adults and children over 12 years of age. Maximum daily dose = 660mg. Only one OTC product marketed: Aleve 220mg tablets. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Bulgaria | Rx | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 2009 | Canada | OTC | Naproxen (base) or its salts in 400mg daily dose. The switch permits the use of different salts in combination or with naproxen base. Naproxen was first switched in 2009 but the wording only permitted the Naproxen salt form to be OTC. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Chile | OTC | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | China | OTC | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Colombia | OTC | Maximum strength 275mg in tablets and soft capsules. OTC also in combination. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Croatia | OTC | 275mg. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Czech Republic | OTC | Oral use, for the relief of mild to moderate pain, e.g. headache, toothaches, backaches, painful menstrual periods, muscle and joint pain accompanying colds and flu, post-traumatic pain in muscles, joints or tendons (sprains and strains), fever. Maximum strength 275mg, maximum single dose 550mg, maximum daily dose 825mg. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Denmark | Rx | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Estonia | OTC | 275mg tablets. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Finland | OTC | 250mg tablets, maximum pack size 10 tablets. |
| 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. |
| 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. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 2011 | Greece | OTC | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Hungary | OTC | Film-coated tablets. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Ireland | Rx | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1994 | Italy | OTC | Also OTC (advertising allowed) under ATC code M02. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Japan | Rx | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Lithuania | OTC | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Mexico | OTC | 220mg capsules, maximum daily dose 660mg, maximum pack size 24 capsules. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | New Zealand | OTC | For oral use. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1996 | Norway | OTC | 20 x 250mg tablets or 10 x 500mg tablets for the treatment of menstrual pain. Pharmacy only supply. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Philippines | Rx | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1998 | Poland | OTC | Maximum 220mg per unit, maximum pack size 20 units. Topical gel up to 3%, maximum pack size 40g. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Portugal | OTC | 200mg tablets, 100mg/g gel. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Romania | Rx | Age group - Adults and children over 16 years old Pharmaceutical form - film coated tablets Dose - 550-1100 mg naproxen in 2 intakes. Do not exceed 1100 mg/day |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Russia | OTC | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 2003 | Singapore | OTC | Naproxen sodium tablets 220mg became available OTC in September 2003. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Slovak Republic | OTC | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Slovenia | OTC | 275mg tablets, maximum pack size 20 tablets. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | South Korea | OTC | — |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1996 | Spain | OTC | As oral analgesic, naproxen 200mg was switched in 1996 (consumer advertising allowed). Maximum daily dose 600mg. For adults and children over 16 only. Topical form (maximum strength 10%) switched in 2004. For adults and children over 12. Combinations are not allowed. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | — | Sweden | OTC | For the treatment of rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, dysmenorrhea without organic cause, acute attacks of migraine and acute pain of mild to moderate intensity. Age group: adults and children over 12 years. Pain: Recommended dosage 250mg when neccesary, maximum 500mg a day. Migraine attack: Recommended dosage 250mg 1-3 times a day, maximum 1250 mg. Maximum pack size: 20 x 250mg tablets, 24 x 220mg film-coated tablets, 20 x 200mg soft capsules. Not for use by children at acute pain. May be supplied on general sale. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1999 | Switzerland | OTC | Topical and oral form, tablets 250 mg, 500 mg, daily dose 1000mg. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1997 | The Netherlands | OTC | Available in tablets of 220mg, 275mg (both indicated in headache, rheumatic or muscular pain, lumbago, dysmenorrhea, pain and fever associated with cold and flu, or after vaccination), and 550mg (indicated in rheumatic or muscular pain and lumbago) in adults and children over 12 years. Maximum pack sizes 40 tablets (220mg), 36 tablets (275mg), 30 tablets (550mg). UAD distribution status (Pharmacy and drugstore only) for packs of up to 12 units of 220mg and 275mg tablets. UA distribution status (Pharmacy only) for larger packs and for 550mg tablets. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 2007 | UK | OTC | Naproxen 250mg switched to non-prescription (Pharmacy-only) status in 2008 for the treatment of primary dysmenorrhoea in women aged between 15 and 50 years. Maximum strength 250mg, maximum dose 500mg, maximum daily dose 750mg, maximum pack size 9 tablets, maximum duration of treatment 3 days. |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 1994 | USA | OTC | Naproxen received OTC approval as internal analgesic / antipyretic with an adult dosage of 200mg / 8-12 hours (oral). |
| Naproxen | M Musculo-skeletal system. Musculo-skeletal system | M01. Antiinflammatory and antirheumatic products | 2007 | Venezuela | OTC | Naproxen sodium 275mg and Naproxen base 250mg. |
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