Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ALDARA
|
Active substances:
|
|
ATC code:
|
D06BB10
|
Dosage form:
|
cream
|
Strength:
|
5%
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
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
|
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
|
Assessment report:
|
|
Description
|
Additional condition
|
Hambaarstil on õigus välja kirjutada
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1060322
|
ALDARA
|
cream
|
5% 250mg 12TK
|
Prescription
|
50% 100%
|
|
12.03.2024
|
|
|
1471306
|
ALDARA
|
cream
|
5% 250mg 24TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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