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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1596719
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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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Route of administration:
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oral use
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Strengh:
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100mg
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Amount in package:
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30TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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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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Summary of product characteristics (SPC):
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 (last updated October 13, 2021)
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Package information leaflet (PIL):
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EST (last updated August 13, 2020)
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Labelling:
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(last updated August 13, 2020)
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Last imported to Estonia:
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September 25, 2023
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Marketing authorization holder:
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KRKA d.d. Novo mesto
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Marketing authorization number:
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832713
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Marketing authorization issued on:
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December 20, 2013
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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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Decentralised
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Percent
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Valid from
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Valid until
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Valid
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Diagnosis
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Doctor's speciality
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Primary
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Age
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Other
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100
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01.10.2023
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Yes
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No
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until 4 years
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50
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01.10.2023
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Yes
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No
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Reference price:
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6,60 EUR
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Under reference price:
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No
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Reference price of daily dose:
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0,44 EUR
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Description
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Additional condition
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Hambaarstil on õigus välja kirjutada
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Entry/Changing date:
October 13, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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