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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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ACLEXA
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Active substances:
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ATC code:
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M01AH01
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Dosage form:
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capsule, hard
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Strength:
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200mg
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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 (last updated April 21, 2023)
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Package information leaflet (PIL):
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EST (last updated May 23, 2022)
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Labelling:
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(last updated May 23, 2022)
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Indication:
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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).
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Safety features:
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Yes
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Marketing authorization holder:
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First Pharma OÜ
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Marketing authorization number:
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1005520
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Marketing authorization issued on:
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May 19, 2020
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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National
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Secondary marketing authorization:
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Yes
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Assessment report:
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(last updated January 8, 2014)
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Description
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Additional condition
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Hambaarstil on õigus välja kirjutada
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1815421
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ACLEXA
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capsule, hard
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200mg 10TK
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Prescription
|
|
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Rumeenia
|
Rumeenia pakend
|
|
1815432
|
ACLEXA
|
capsule, hard
|
200mg 20TK
|
Prescription
|
|
|
|
Rumeenia
|
Rumeenia pakend
|
|
1815443
|
ACLEXA
|
capsule, hard
|
200mg 30TK
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Prescription
|
100% 50%
|
13,20
|
30.08.2023
|
Rumeenia
|
Rumeenia pakend
|
|
1815454
|
ACLEXA
|
capsule, hard
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200mg 40TK
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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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