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 April 21, 2023)
Package information leaflet (PIL): EST  (last updated May 23, 2022)
Labelling:  (last updated May 23, 2022)
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: 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 
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
1815421  ACLEXA  capsule, hard  200mg 10TK  Prescription        Rumeenia  Rumeenia pakend 
1815432  ACLEXA  capsule, hard  200mg 20TK  Prescription        Rumeenia  Rumeenia pakend 
1815443  ACLEXA  capsule, hard  200mg 30TK  Prescription  100% 50%  13,20  12.04.2024  Rumeenia  Rumeenia pakend 
1815454  ACLEXA  capsule, hard  200mg 40TK  Prescription        Rumeenia  Rumeenia pakend 
1815465  ACLEXA  capsule, hard  200mg 50TK  Prescription        Rumeenia  Rumeenia pakend 
1815476  ACLEXA  capsule, hard  200mg 60TK  Prescription        Rumeenia  Rumeenia pakend 
1815487  ACLEXA  capsule, hard  200mg 90TK  Prescription        Rumeenia  Rumeenia pakend 
1815498  ACLEXA  capsule, hard  200mg 100TK  Prescription        Rumeenia  Rumeenia pakend 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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