Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1890895
|
Name of medicinal product:
|
NEOTIGASON
|
Active substances:
|
|
ATC code:
|
D05BB02
|
Dosage form:
|
capsule, hard
|
Route of administration:
|
oral use
|
Strengh:
|
10mg
|
Amount in package:
|
30TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
Poola pakend
|
Indication:
|
Severe psoriasis vulgaris resistant to other forms of therapy, especially erythrodermic and pustulous forms.
Palmo-plantar keratodermia.
Palmo-plantar pustulosis.
Severe congenital ichthyosis.
Morbus Darier (keratosis follicularis).
Pityriasis rubra pilaris.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated January 30, 2023)
|
Package information leaflet (PIL):
|
EST (last updated January 30, 2023)
|
Labelling:
|
(last updated January 30, 2023)
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Ideal Trade Links UAB
|
Marketing authorization number:
|
1091923
|
Marketing authorization issued on:
|
January 30, 2023
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
National
|
Secondary marketing authorization:
|
Yes
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
L40-L40; Q82.8-Q82.8; L86-L86; M07-M07; Q80-Q80; L43-L43
|
Dermatoveneroloog, Pediaater
|
No
|
from 63 years
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
L40-L40; Q82.8-Q82.8; L86-L86; M07-M07; Q80-Q80; L43-L43
|
Dermatoveneroloog, Pediaater
|
No
|
4 years - 17 years
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
L40-L40; Q82.8-Q82.8; L86-L86; M07-M07; Q80-Q80; L43-L43
|
Dermatoveneroloog, Pediaater
|
No
|
|
|
75
|
01.01.2024
|
01.04.2024
|
Yes
|
L40-L40; Q82.8-Q82.8; L86-L86; M07-M07; Q80-Q80; L43-L43
|
Pediaater, Dermatoveneroloog
|
No
|
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
L40-L40; Q82.8-Q82.8; L86-L86; M07-M07; Q80-Q80; L43-L43
|
Pediaater, Dermatoveneroloog
|
No
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
L40-L40; Q82.8-Q82.8; L86-L86; M07-M07; Q80-Q80; L43-L43
|
Pediaater, Dermatoveneroloog
|
No
|
until 4 years
|
|
Reference price:
|
26,57 EUR
|
Under reference price:
|
Yes
|
Reference price of daily dose:
|
3,10 EUR
|
Entry/Changing date:
March 13, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere