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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1471306
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Name of medicinal product:
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ALDARA
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Active substances:
|
|
ATC code:
|
D06BB10
|
Dosage form:
|
cream
|
Route of administration:
|
cutaneous use
|
Strengh:
|
5%
|
Amount in package:
|
250mg 24TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Imiquimod cream is indicated for the topical treatment of :
External genital and perianal warts (condylomata acuminata) in adults.
Small superficial basal cell carcinomas (sBCCs) in adults.
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or
scalp in immunocompetent adult patients when size or number of lesions limit the efficacy
and/or acceptability of cryotherapy and other topical treatment options are contraindicated or
less appropriate.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
VIATRIS HEALTHCARE Limited
|
Marketing authorization number:
|
EU/1/98/080
|
Marketing authorization issued on:
|
August 17, 2001
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Hambaarstil on õigus välja kirjutada
|
|
Entry/Changing date:
January 25, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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