Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1815454
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: 40TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: Rumeenia pakend
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 February 25, 2021)
Package information leaflet (PIL): EST  (last updated May 23, 2022)
Labelling:  (last updated May 23, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: First Pharma OÜ 
Marketing authorization number: 1005520 
Marketing authorization issued on: May 19, 2020 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: May 23, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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