Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1736580
|
Name of medicinal product:
|
EXOLORFIN
|
Active substances:
|
|
ATC code:
|
D01AE16
|
Dosage form:
|
medicated nail lacquer
|
Route of administration:
|
cutaneous use
|
Strengh:
|
50mg 1ml
|
Amount in package:
|
2.5ml 1TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
pudel
|
Indication:
|
Treatment of onychomycosis caused by dermatophytes, yeasts or moulds, without nail matrix involvement in adults.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated December 27, 2019)
|
Package information leaflet (PIL):
|
EST (last updated October 17, 2023)
|
Labelling:
|
(last updated December 27, 2019)
|
Last imported to Estonia:
|
March 22, 2024
|
Marketing authorization holder:
|
Sandoz Pharmaceuticals d.d.
|
Marketing authorization number:
|
983319
|
Marketing authorization issued on:
|
April 2, 2019
|
Marketing authorization expires on:
|
March 20, 2025
|
Marketing authorization procedure type:
|
Decentralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
Reference price:
|
24,00 EUR
|
Under reference price:
|
Yes
|
Reference price of daily dose:
|
0,48 EUR
|
Entry/Changing date:
March 20, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere