Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1044470
|
Name of medicinal product:
|
KREON 25 000 U
|
Active substances:
|
|
ATC code:
|
A09AA02
|
Dosage form:
|
gastro-resistant capsule, hard
|
Route of administration:
|
oral use
|
Strengh:
|
25000ühik+18000ühik+1000ühik
|
Amount in package:
|
20TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated March 10, 2023)
|
Package information leaflet (PIL):
|
EST (last updated March 10, 2023)
|
Labelling:
|
(last updated December 15, 2022)
|
Last imported to Estonia:
|
February 29, 2024
|
Marketing authorization holder:
|
VIATRIS HEALTHCARE Limited
|
Marketing authorization number:
|
342901
|
Marketing authorization issued on:
|
February 9, 2001
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
National
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
E84-E84
|
Pediaater, Pulmonoloog
|
Yes
|
until 4 years
|
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
E84-E84
|
Pediaater, Pulmonoloog
|
Yes
|
|
|
Reference price:
|
8,50 EUR
|
Under reference price:
|
No
|
Reference price of daily dose:
|
0,17 EUR
|
Entry/Changing date:
August 25, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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