Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ACLEXA
Active substances:
Estonian, English, Latin
ATC code: M01AH01
Dosage form: capsule, hard
Strength: 200mg
Legal status for supply*: Subject to medicinal prescription
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)
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
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 
Assessment report:  (last updated January 8, 2014) 
Description Additional condition
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1596775  ACLEXA  capsule, hard  200mg 10TK  Prescription           
1596786  ACLEXA  capsule, hard  200mg 20TK  Prescription           
1596797  ACLEXA  capsule, hard  200mg 30TK  Prescription  50% 100%  13,20  27.11.2023     
1596809  ACLEXA  capsule, hard  200mg 40TK  Prescription           
1596810  ACLEXA  capsule, hard  200mg 50TK  Prescription           
1596821  ACLEXA  capsule, hard  200mg 60TK  Prescription           
1596832  ACLEXA  capsule, hard  200mg 90TK  Prescription           
1596843  ACLEXA  capsule, hard  200mg 100TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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