Product class:
|
Authorized package
|
Medicinal product class:
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For human use
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Package code:
|
1314829
|
Name of medicinal product:
|
IMAZOL
|
Active substances:
|
|
ATC code:
|
D01AC01
|
Dosage form:
|
cutaneous paste
|
Route of administration:
|
cutaneous use
|
Strengh:
|
10mg 1g
|
Amount in package:
|
30g 1TK
|
Legal status for supply*:
|
Not subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Dermatomycoses that are susceptible to treatment with clotrimazole (e.g. dermatomycoses caused by Trichophyton-species, Candida-species or Malassezia furfur) for example nappy rash caused by yeasts.
/
/ is indicated in adults, adolescents and children above 1 month of age.
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
(last updated June 26, 2017)
|
Package information leaflet (PIL):
|
EST (last updated April 29, 2020)
|
Translation of package information leaflet into Russian:
|
RUS (last updated April 29, 2020)
|
Translation of package information leaflet into English:
|
ENG (last updated April 29, 2020)
|
Labelling:
|
(last updated June 26, 2017)
|
Last imported to Estonia:
|
December 8, 2020
|
Marketing authorization holder:
|
Laboratoires Bailleul S.A.
|
Marketing authorization number:
|
589008
|
Marketing authorization issued on:
|
June 20, 2008
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Mutual recognition
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
November 20, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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