ACLEXA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1815487
Name of medicinal product:
ACLEXA
Active substances:
Celecoxib
Estonian
,
English
,
Latin
ATC code:
M01AH01
Dosage form:
capsule, hard
Route of administration:
oral use
Strengh:
200mg
Amount in package:
90TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Rumeenia pakend
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
Summary of product characteristics (SPC):
(last updated 21 April 2023)
Package information leaflet (PIL):
EST
(last updated 23 May 2022)
Labelling:
(last updated 23 May 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
First Pharma OÜ
Marketing authorization number:
1005520
Marketing authorization issued on:
19 May 2020
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Secondary marketing authorization:
Yes
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: 21 April 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription