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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1827222
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Name of medicinal product:
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DIMESTIL
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Active substances:
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|
ATC code:
|
D04AA13
|
Dosage form:
|
gel
|
Route of administration:
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cutaneous use
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Strengh:
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1mg 1g
|
Amount in package:
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30g 1TK
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Legal status for supply*:
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Not subject to medicinal prescription
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Class of active substance:
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|
Additional information:
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|
Indication:
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[Invented name] is indicated in adults, adolescents and children aged 1 month and older for the short term relief of pruritus associated with dermatoses, urticaria, insect bites, sunburn and superficial skin burns (first degree).
|
Safety features:
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No
|
Summary of product characteristics (SPC):
|
(last updated May 9, 2022)
|
Package information leaflet (PIL):
|
EST (last updated May 9, 2022)
|
Translation of package information leaflet into Russian:
|
RUS (last updated May 9, 2022)
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Translation of package information leaflet into English:
|
ENG (last updated May 9, 2022)
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Labelling:
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(last updated May 9, 2022)
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Last imported to Estonia:
|
March 20, 2024
|
Marketing authorization holder:
|
Grindeks AS
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Marketing authorization number:
|
1061522
|
Marketing authorization issued on:
|
May 9, 2022
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Marketing authorization expires on:
|
May 9, 2027
|
Marketing authorization procedure type:
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Decentralised
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Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
May 9, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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