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: 100mg
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: 832713 
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
1596696  ACLEXA  capsule, hard  100mg 10TK  Prescription           
1596708  ACLEXA  capsule, hard  100mg 20TK  Prescription           
1596719  ACLEXA  capsule, hard  100mg 30TK  Prescription  50% 100%  6,60  27.11.2023     
1596720  ACLEXA  capsule, hard  100mg 40TK  Prescription           
1596731  ACLEXA  capsule, hard  100mg 50TK  Prescription           
1596742  ACLEXA  capsule, hard  100mg 60TK  Prescription           
1596753  ACLEXA  capsule, hard  100mg 90TK  Prescription           
1596764  ACLEXA  capsule, hard  100mg 100TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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