Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1401882
Name of medicinal product: ARCOXIA
Active substances:
Estonian, English, Latin
ATC code: M01AH05
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 60mg
Amount in package: 98TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. is indicated in adults and adolescents 16 years of age and older for the short-term treatment of moderate pain associated with dental surgery. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated July 7, 2022)
Package information leaflet (PIL): EST  (last updated April 25, 2023)
Labelling:  (last updated July 7, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Organon N.V. 
Marketing authorization number: 393202 
Marketing authorization issued on: August 16, 2002 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: April 19, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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