Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1596832
Name of medicinal product: ACLEXA
Active substances:
Celecoxib
Estonian, English, Latin
ATC code: M01AH01
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 200mg
Amount in package: 90TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated October 13, 2021)
Package information leaflet (PIL): EST  (last updated August 13, 2020)
Labelling:  (last updated August 13, 2020)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 832913 
Marketing authorization issued on: December 20, 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: October 13, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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