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KREON 35 000 U
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1741890
Name of medicinal product:
KREON 35 000 U
Active substances:
Lipase+Amylase+Protease
Estonian
,
English
,
Latin
ATC code:
A09AA02
Dosage form:
gastro-resistant capsule, hard
Route of administration:
oral use
Strengh:
35000ühik+25200ühik+1400ühik
Amount in package:
60TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Pancreatic enzyme replacement treatment in pancreatic excocrine insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, pancreatectomy or pancreatic cancer). Creon gastro-resistant capsules are indicated in children, adolescents and adults.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated January 8, 2024)
Package information leaflet (PIL):
EST
(last updated January 8, 2024)
Labelling:
(last updated September 11, 2023)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
VIATRIS HEALTHCARE Limited
Marketing authorization number:
974718
Marketing authorization issued on:
October 30, 2018
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: January 8, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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