Product class:
|
Authorized package
|
Medicinal product class:
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For human use
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Package code:
|
1698857
|
Name of medicinal product:
|
LOMEXIN
|
Active substances:
|
|
ATC code:
|
G01AF12
|
Dosage form:
|
vaginal capsule, soft
|
Route of administration:
|
vaginal use
|
Strengh:
|
600mg
|
Amount in package:
|
1TK
|
Legal status for supply*:
|
Not subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
For the treatment of vulvovaginal candidiasis in adolescents more than 16 years and adults. For treatment in women over 60 years, prior consultation with a physician is required.
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
(last updated September 7, 2023)
|
Package information leaflet (PIL):
|
EST (last updated September 6, 2021)
|
Translation of package information leaflet into Russian:
|
RUS (last updated September 6, 2021)
|
Translation of package information leaflet into English:
|
ENG (last updated September 6, 2021)
|
Labelling:
|
(last updated June 28, 2021)
|
Last imported to Estonia:
|
September 14, 2023
|
Marketing authorization holder:
|
Recordati Ireland Limited
|
Marketing authorization number:
|
923316
|
Marketing authorization issued on:
|
November 8, 2016
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Decentralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Ämmaemandal on õigus välja kirjutada
|
|
Entry/Changing date:
September 7, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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