Product class: Authorized package
Medicinal product class: For human use
Package code: 1815443
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: 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 21 April 2023)
Package information leaflet (PIL): EST  (last updated 23 May 2022)
Labelling:  (last updated 23 May 2022)
Last imported to Estonia: 12 April 2024
Marketing authorization holder: First Pharma OÜ 
Marketing authorization number: 1005520 
Marketing authorization issued on: 19 May 2020 
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  05/04/2024     Yes      No      
100  05/04/2024     Yes      No  until 4 years   
Reference price: 13.20 EUR 
Under reference price: Yes 
Reference price of daily dose: 0.44 EUR 
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: 21 April 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription