Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1861365
Name of medicinal product: ACLEXA
Active substances:
Estonian, English, Latin
ATC code: M01AH01
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 200mg
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: Poola 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 November 30, 2021)
Package information leaflet (PIL): EST  (last updated November 30, 2021)
Labelling:  (last updated November 30, 2021)
Last imported to Estonia: June 28, 2022
Marketing authorization holder: Ideal Trade Links UAB 
Marketing authorization number: 1047921 
Marketing authorization issued on: November 30, 2021 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  01.10.2022     Yes      No      
100  01.10.2022     Yes      No  until 4 years   
Reference price: 14,70 EUR 
Under reference price: Yes 
Reference price of daily dose: 0,49 EUR 
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: November 30, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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