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AKLIEF
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1848887
Name of medicinal product:
AKLIEF
Active substances:
Trifarotene
Estonian
,
English
,
Latin
ATC code:
D10AD06
Dosage form:
cream
Route of administration:
cutaneous use
Strengh:
50mcg 1g
Amount in package:
75g 1TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Aklief is indicated for the cutaneous treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated October 4, 2021)
Package information leaflet (PIL):
EST
(last updated November 15, 2022)
Labelling:
(last updated October 4, 2021)
Last imported to Estonia:
Never imported to Estonia
:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions
to State Agency of Medicines
.
State Agency of Medicines
Marketing authorization
Marketing authorization holder:
Galderma International
Marketing authorization number:
1041821
Marketing authorization issued on:
October 4, 2021
Marketing authorization expires on:
October 4, 2026
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: November 15, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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